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Jun-12-2011 22:14printcomments

Oxycontin Tsunami Claims Thousands

On this first day of a new year, we join the world in feeling enormous sadness over a great human tragedy... The carnage is of a scale that defies comprehension." US President George W. Bush (January 2005 about a Tsunami in Indonesia)

Nazi Dr. Josef Mengele was known for his experiments on Holocaust children during Hitler's Third Reich.
Nazi Dr. Josef Mengele was known for his experiments on Holocaust children during Hitler's Third Reich.

(MYRTLE BEACH, S.C.) - The above quotation will apply to the Tsunami of OxyContin addiction and death in every state in the country when Purdue Pharma obtains approval for clinical trials of non-malignant pain in children -- ages 6 to 17 -- beginning in September 2011.

In April 2011, I wrote about these clinical trials that were being driven by Purdue Pharma and made a comparison of Purdue Pharma's physician, Dr. Deborah Steiner and Dr. Josef Mengele, the "angel of death" under Adolf Hitler. Any family member of Dr. Steiner wanting to defend her involvement in these clinical trials of our children on OxyContin, don't waste your time -- I am not interested in anyone defending a physician who is well aware of the devastation this drug has caused throughout the country and Canada in addiction and death. These clinical trials"will open the "floodgates" to a Tsunami -- only childrens' lives will be destroyed by sheer greed and evil. And yes the name Dr. Mengele is very well intended for any clinical trial involving OxyContin and children.

Below is the "latest news" on the clinical trials by Purdue Pharma of children to be used as guinea pigs on OxyContin:

Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

This study is not yet open for participant recruitment.

Verified on June 2011 by Purdue Pharma LP

First Received on June 7, 2011. Last Updated on June 8, 2011 History of Changes

Sponsor: Purdue Pharma LP
Information provided by: Purdue Pharma LP Identifier: NCT01369615


The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.

Condition Intervention Phase
Drug: Oxycodone hydrochloride controlled-release tablets
Phase III

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study

Resource links provided by NLM:

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • The number of participants with adverse events as a measure of safety. [ Time Frame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 135
Study Start Date: September 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Oxycodone HCl controlled-release: Experimental

Oxycodone hydrochloride (HCl) controlled-release

Intervention: Drug: Oxycodone hydrochloride controlled-release tablets
Drug: Oxycodone hydrochloride controlled-release tablets

Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.

Other Name: OxyContin


Ages Eligible for Study: 6 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No


Inclusion Criteria include:

  • Male and female patients aged 6 to 17 years, inclusive, who completed the 4-week study drug treatment in study OTR3001 and who, based on the investigator's judgment, will benefit from continuing treatment with oxycodone HCl CR 20 to 240 mg/day for the management of moderate to severe malignant or nonmalignant pain;
  • Patients must have tolerated the oxycodone HCl CR therapy in OTR3001 as demonstrated at the start of the study;
  • Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.

Exclusion Criteria include:

  • Patients with ongoing adverse events in OTR3001 that, in the investigator's opinion, disqualify them from participation in the study;
  • Female patients who are pregnant or lactating;

  • Patients requiring opioid at doses equivalent to < 20 mg/day or > 240 mg/day oxycodone for treatment of their malignant or nonmalignant pain;
  • Patients who are allergic to oxycodone or have a history of allergies to other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation]);
  • Patients who are contraindicated for the use of opioids;
  • Patients who are currently being maintained on methadone for pain;
  • Patients who have an abnormality on vital signs, physical examination, or laboratory testing significant enough that the investigator deems the patient is not appropriate for the study;
  • Patients who have any planned surgery during the course of the study, with the exception of the placement of central or peripheral venous access devices;
  • Patients currently taking an investigational medication/therapy other than the study drug (oxycodone HCl CR) at the start of screening or during the study.

Other protocol specific inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its identifier: NCT01369615


Contact: Deborah Steiner, MD 203-588-7413

Sponsors and Collaborators

Purdue Pharma LP

More Information

Additional Information:

No publications provided

Responsible Party: Purdue Pharma LP ( Medical Monitor ) Identifier: NCT01369615 History of Changes
Other Study ID Numbers: OTR3002, 2011-002235-26
Study First Received: June 7, 2011
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Malignant pain
Nonmalignant pain
Moderate to severe

Additional relevant MeSH terms:

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid processed this record on June 09, 2011

Just when you think it might be safe to go back into the water, Purdue Pharma's "lobbying group" the American Pain Foundation issues something they call a "Media Outreach" concerning their self-proclaimed "undertreatment of pain" in America. It is shown below:

Media Outreach

Pain is News!

Do you get frustrated when you read unbalanced news coverage about prescription medication abuse? Have you faced barriers in your pain care journey that you would like to share with others, so that others might not needlessly suffer? Do you wish that you had the tools to respond to news reports and reach out to reporters to tell your side?

This section includes information about getting started with media outreach for pain advocacy, from building media contacts to sample letters to the editors and Op-Eds.

Pain is news…which can mean both good news and bad news. The good news is that the undertreatment of pain, as a major U.S. healthcare problem, is getting media attention. The bad news is that there have also been many one-sided news stories related to pain and pain medications. The abuse and diversion of opioids, for example, is a focus of local and national media, particularly surrounding celebrities. And, while most of these sensationalized stories have focused on the dangers of pain medications, few have described the value of these medications, when taken as prescribed, for peo¬ple with serious pain.

Because people tend to believe that what they see, hear, and read in the news is true, these stories, both the good and the bad, influence the way that the public, healthcare professionals, policy makers, law enforcement, and others understand and respond to pain and pain management issues. As a pain advocate, you can play an important role in shaping accurate, current, and compelling news stories that bring wide attention to the undertreatment of pain, dispel myths and misconceptions about pain and pain management, and maximize the impact of your advocacy efforts.

Are you interested in helping to provide hope and inspiration to people in pain in your area by telling your personal pain story through the media? Are you interested in becoming more involved in pain advocacy through the American Pain Foundation Action Network? If so, please contact us


Be sure to visit the American Pain Foundation’s For the Media section for fact sheets, surveys, backgrounders and position statements that you can send to the media.

Types of Media Reports

You can use the media to promote pain messages and the campaign in a variety of ways. The types of articles found in newspapers are:

News stories — These are stories that are newsworthy, have urgency, and are time-sensitive. Called “hard news,” these are stories that appear on, or near, the front page of newspapers, and are close to the beginning of radio and television news shows. If you are doing a major "first-ever" event or if there is some breaking pain news in your area, send a news release with other supporting materials to the media outlets, and follow up with phone calls.

Feature/human interest stories — Also called “soft news,” these stories often focus on the “human side” of the issue. Unlike news stories, they are less time-sensitive, more subjective, and often contain an opinion.

Letters to the Editor — These are usually written by readers for the opin¬ion section of newspapers and magazines. Letters to the Editor are written either in response to something that's been published in the paper, or about something significant happening in your area. This provides an out¬standing opportunity for you to get out pain messages, particularly at times when you are holding events. Letters should be kept short—absolutely no more than 500 words, and should focus on one major point. Be sure to check publications' requirements online or in the newspaper.

Op-Ed pieces — Longer than Letters to the Editor, they are usually written by "an expert"—someone who can speak from experience. Op-Ed pieces are usually about 500–800 words and are written like a news story. It should have a great lead paragraph to capture interest, and it should present a strong point of view or opinion. When sending this to the Op-Ed/opinion page editor, include a brief bio of the author that gives credentials and tells why you are an authority on the subject. (The more well-known, or well credentialed the author is, the better chance of having the piece published).

Calendar of Events — This is a good place to "advertise" your events and invite people to attend. Do not assume that your event will be included in the calendar of events when you send out your press materials. The same people usually do not handle both calendar information and stories (unless it is a very small local paper or radio or TV station). Keep in mind that there’s usually a long lead time for calendar listings, usually 4 to 6 weeks.

Letters to the Editor and Op-Eds

These examples provide a starting point for opinion pieces in terms of topic, messages and format/length. Rapid response to breaking issues are important for opinion submissions, so if you see an article that you feel is either unbalanced or deserves praise, a quick response ensures the best chance for it to run. Your submission should be original and in response to a specific article or issue.

Many local newspapers offer guidance on their Web sites in terms of writing and placing op-eds and letters to the editor. Read and follow this guidance. A few more tips include:

  • DO NOT submit the same op-ed to multiple publications; if you submit to more than one, select a separate topic.
  • DO build your opinion piece around key messages.
  • DO take the time to personalize with your story. Localize with relevant statistics such as state pain policy grades or incidence.
  • DO keep in mind that your opinion piece does not have to take an alternate view to what was published – you can also write in to comment a paper on balanced news coverage. This can be a good way to extend the reach of a positive story!
  • DO print out your letter to the editor or op-ed to proofread prior to submitting.
  • If you submit a letter to the editor, you do not need to follow up. If you submit an op-ed, you should plan to follow up with the Opinion Editor to ensure receipt.


I am interested in submitting an article to "Pain is News" for the American Pain Foundation. My article will address "Death is News" in the overtreatment of pain in every state in the country as well as Canada because of your clever marketing and the billions of dollars that Purdue Pharma funds you to convince the medical profession pain is undertreated. Pain is not undertreated -- greed at the cost of human life -- and now children -- is why the American Pain Foundation and any physician involved in clinical studies of children taking OxyContin deserves to be compared to Dr. Josef Mengele, a true angel of death.

LP -- I believe Shakespeare once said -- To be or not to be -- it's all about me.

Visit: Kids: the New Guinea Pigs for Oxycontin Maker Purdue Pharma - Marianne Skolek

_____________________________________ Reporter Marianne Skolek, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

Marianne Skolek
National Activist for Victims of OxyContin and
Purdue Pharma - a criminally convicted pharmaceutical company
Staff Writer,

Comments Leave a comment on this story.

All comments and messages are approved by people and self promotional links or unacceptable comments are denied.

Lorna Ostroff June 13, 2011 10:04 pm (Pacific time)

I believe oxycontin should be used in certain pain illnesses. I myself as on it for 6 years. I did not die because I took as directed and didn't overdose trying to get high. This medication is needed. But, they must be very careful with kids with cancer and tumors. Children suffer of pain also.

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