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TJP
Apr-23-2011 20:47
Kids: the New Guinea Pigs for Oxycontin Maker Purdue Pharma
Marianne Skolek Salem-News.com"The more we do to you, the less you seem to believe we are doing it." - Dr. Josef Mengele, Infamous Nazi Doctor
 Courtesy: hubpages.com |
(MYRTLE BEACH, Calif.) - Purdue Pharma, maker of the criminally marketed drug, OxyContin is actively "recruiting" participants for clinical studies in the treatment of "moderate" to "severe" pain -- in children ages 6 to 16!!!
Every state in the country - as well as Canada - is fighting an unwinnable war in addiction, death and abuse of OxyContin because of the criminal marketing by Purdue Pharma of this drug -- as less likely to be addictive or abused. The company pleaded guilty to these charges in Federal Court and was sentenced and fined in 2007.
Is the FDA going to allow Purdue Pharma to further addict and kill our most vulnerable and defenseless -- our children? Will members of Congress and the Senate step up and end this greed and madness perpetrated by an out of control private pharmaceutical company - Purdue Pharma?
The reference below in Purdue Pharma's recruitment for children indicates that "Patients must not require more than a 240-mg total daily dose of oxycodone HCI CR tablets." There would be no further requirement of a 240 mg total daily dose to a child -- there would be no tomorrow for that child.
When the "Angel of Death", Dr. Josef Mengele visited his child "experiments" in death camps during the Holocaust, he introduced himself as "Uncle Mengele" -- and offered them sweets. Some survivors remember that despite his grim acts, he was also called "Mengele the Protector."
So Deborah Steiner, MD, Purdue Pharma, when you recruit these children ages 6 to 16 -- and give them the same fate that scores of victims have fallen prey to in every state in the country in death and addiction from OxyContin -- should these same children call you -- "Aunt Steiner" or "Steiner the Protector?"
Here is the recruitment filing Purdue Pharma is using to market for young children.
Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
| Sponsor: | Purdue Pharma LP |
|---|---|
| Information provided by: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT01192295 |
| Condition | Intervention | Phase |
|---|---|---|
| Pain | Drug: Oxycodone HCl controlled-release tablets | Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Intervention Model: Single Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics |
- The number of participants with adverse events as a measure of safety. [ Time Frame: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). ] [ Designated as safety issue:
Yes ]
- To characterize the efficacy and provide additional pharmacokinetics (PK) data of oxycodone hydrochloride controlled-release tablets [ Time Frame: 2-4 and 4-6 hours (hrs) after the first dose on Day 1 and immediately pre-dose and 2-4 hrs after dose at Visit 2 and/or Visit 3. ] [ Designated as safety issue:
No ] To characterize the efficacy and provide additional pharmacokinetics (PK) data for a population PK model of oxycodone hydrochloride controlled-release tablets in opioid tolerant pediatric patients aged 6 to16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
| Estimated Enrollment: | 135 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Oxycodone HCl controlled-release: Experimental Oxycodone hydrochloride (HCl) controlled-release (CR) Intervention: Drug: Oxycodone HCl controlled-release tablets | Drug: Oxycodone HCl controlled-release tablets Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours. |
| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- Male and female patients aged 6 to 16 years, inclusive, who are expected to require ongoing around-the-clock opioid treatment equivalent to at least 20-mg daily dose of oxycodone for at least 2 weeks for management of moderate to severe (based on the investigator's judgment) malignant or nonmalignant pain.
- Patients must be opioid tolerant, ie, have been treated with opioids for at least the 5 consecutive days prior to dosing and with at least 20 mg daily of oxycodone or the equivalent during at least the last 48 hours prior to the start of study drug dosing and have tolerated the therapy, as demonstrated at the start of study drug dosing.
- Patients who are currently using transdermal fentanyl should have been on the patch for at least 3 days before removing the patch and oxycodone hydrochloride (HCl) controlled-release (CR) treatment can only be initiated at least 18 hours following the removal of the transdermal fentanyl patch.
- Patients must not require more than a 240-mg total daily dose of oxycodone HCl CR tablets.
- Patients must be willing and able to swallow the oxycodone HCl CR tablets whole.
- Patients must not be currently on an investigational medication/therapy at the start of screening or during the study.
- Female patients who are pregnant or lactating.
- 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 have received epidural opioids < 2 hours prior to the first dose of study drug or who have received epidural morphine < 12 hours prior to the first dose of study drug.
- Patients who are contraindicated for the use of opioids.
- Patients who are contraindicated for blood sampling.
- Patients who are currently being maintained on methadone for pain.
- 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 who have had surgery within 120 hours prior to Day 1 (day of first dose of study drug).
| Contact: Deborah Steiner, MD | 203-588-7413 | deborah.steiner@pharma.com |
| United States, Arizona | |
| Maricopa Medical Center | Recruiting |
| Phoenix, Arizona, United States, 85008 | |
| Contact: David Rosenberg, MD | |
| Principal Investigator: David Rosenberg, MD | |
| United States, California | |
| Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Peter Przekop, MD | |
| Principal Investigator: Peter Przekop, MD | |
| LS Packard Children's Hospital | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Elliot Krane, MD | |
| Principal Investigator: Elliot Krane, MD | |
| Bayview Research Group, LLC | Recruiting |
| Paramount, California, United States, 90723 | |
| Contact: Mohammad Riaz, MD | |
| Principal Investigator: Mohammad Riaz, MD | |
| United States, Colorado | |
| The Children's Hospital | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Jeffrey Galinkin, MD | |
| Principal Investigator: Jeffrey Galinkin, MD | |
| United States, Pennsylvania | |
| Penn State Hershey Children's Hospital | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Andrew S. Freiberg, MD | |
| Principal Investigator: Andrew S. Freiberg, MD | |
| United States, Texas | |
| Children's Medical Ctr of Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Peter Szmuk, MD | |
| Principal Investigator: Peter Szmuk, MD | |
| Estonia | |
| Tallinn Children's Hospital | Recruiting |
| Tallinn, Estonia, 13419 | |
| Contact: Kadri Saks, MD | |
| Principal Investigator: Kadri Saks, MD | |
| Tartu University Hospital | Recruiting |
| Tartu, Estonia, 51014 | |
| Contact: Karin Varik, MD, Ph.D. | |
| Principal Investigator: Karin Varik, MD, Ph.D. | |
Additional Information:
No publications provided
| Responsible Party: | Purdue Pharma LP ( Medical Monitor ) |
| ClinicalTrials.gov Identifier: | NCT01192295 History of Changes |
| Other Study ID Numbers: | OTR3001, 2010-020471-23 |
| Study First Received: | August 30, 2010 |
| Last Updated: | March 28, 2011 |
| Health Authority: | United States: Food and Drug Administration; Estonia: State Agency of Medicines |
Keywords provided by Purdue Pharma LP:
| Malignant pain Nonmalignant pain Pediatric Opioid Moderate to severe malignant or nonmalignant pain |
Additional relevant MeSH terms:
| Oxycodone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs | Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on April 14, 2011
Salem-News.com 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 Correspondent, Salem-News.com
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Comments
Megan Steiner April 30, 2011 3:07 am (Pacific time)
Miss Skolek, my name is Megan Steiner. I am Deborah Steiner's daughter, the daughter of the woman you dare to compare to Mengele. I am also a chronically ill teenager - since the age of 12 I have suffered immensely due to a one in ten million condition, and "Aunt Steiner" has suffered by my side, watching her child misdiagnosed, mistreated, and literally screaming in pain more often than not. My mother has indeed been my "protector" - she worked in this field prior to my illness, and she did so and does so because she believes that no child should suffer. If it weren't for medications such as Oxycontin, which I have been prescribed in the past, though I am currently on another opiate, I would still be bedridden. Without my pain, I have been able to not only get out of bed, but to get into one of the top colleges in the country and battle my illness on my feet. Without people like my mother, who you have so cruelly demonized, children and teens like me could never live, not a real life. Addiction and dependency are real issues, of course, but does that mean that children in severe pain, those who truly need relief from the hell that is chronic pain, should be denied the possibility to escape the prisons that their bodies have become? Opiates were my last resort - nobody wanted to prescribe a child opiates - but they have given me a chance at a real life, one that I cherish. So while you so sarcastically and hatefully call my mother "Steiner the protector," I do view my mother as a true protector - she protects the hopes for a pain-free, or at least a less painful life for very sick children who so desperately need that hope whilst drowning in the depths of despair and hopelessness that come with a life-sentence of pain when that life has barely begun.
My mother is no Dr. Mengele, Miss Skolek. She is a doctor who believes in helping children, not tricking them. Many drugs can be abused, and many drug companies produce such drugs. I am sorry for your daughter's fate, but for every girl like your daughter, there is a girl like me. And as you fight for children like your daughter, protecting them from pharmaceutical companies, my mother stands by me and those like me every day, hoping to help build us a better, pain-free future.
Perhaps, Miss Skolek, when you next choose vilify some MD, you will take a moment to consider that, perhaps, behind that MD is a good person with a loving family.
Sincerely,
Megan Steiner, or as I may now call myself, ["Steiner the Protector" of my mom"]
Editor: Right, well it is quite obvious that you would rally for this woman under any conditions because she is your MOM. Funny that nobody else is put out by this, in fact it is quite the opposite. People are grossed out and sickened by these money grubbing drug pushers who are all in it for the profits. Hell, I'll bet you have some digs don't you? Unlike all of the kids resting six feet underground because of overdoses and issues related to good old Oxycontin and its contemporaries, your mom probably has a nice mansion for you to live and and what, the best schools? There are methods at pain management but obviously you would only know about the ones that are drug induced. I would like to know if you are even who you claim to be. I am laughing, calling Marianne 'cruel' and claiming she 'demonizes' your mom, please... All of you on hard drugs, no matter what, these doctors are making you into addicts. Medical marijuana is the unaddressed answer because the corporate cronies keep 'demonizing' that substance with a high level of inaccuracy. Write a letter to the drug czar.
curtis April 26, 2011 4:30 pm (Pacific time)
I am a former addict to oxycontin and if I only knew how badly it was gonna affect my life I never would have started to take it. I'm not trying to sound like a broken record but every addicted person,when really thinking about it, feels the same way. I was using 2000mg a day, which never got me high anymore and I lost everything I had dear to me including my wife and three kids. I can only say that starting children on this experiment is just asking for more people to become addicted and potentially being responsible for starting them on a path to addiction. So I think its wrong and parents shouldn't decide their fate,the children should make that decision when they become adults to make the choice for themselves.
G April 24, 2011 5:52 pm (Pacific time)
Kids dont deserve pain relief??
Sarah_H April 24, 2011 5:09 pm (Pacific time)
Why on earth would anyone allow or want to put their sick child on a trial of any drug that does not cure illness? unless the parents are junkies and are trying to get to the childs meds. back when i was a practicing addict (heroin) and was stupid enough to get on the methadone clinic- there were so many high school kids there on methadone due to addiction to Oxy. I guess their parents signed consent because they didnt know what else to do and the kids and clinic staff convinced the parents this was "treatment". most all of the kids i got to know from the clinic have all died from overdoses or are still on methadone (plus oxy, plus xanax, plus various patches). like any methadone clinic- there is a lot of buying/selling/using/trading that goes on in the parking lot- all these kids knew how to shoot Oxy. somethng an old timer like me didnt even know could be done. i sucked it up and went to rehab and have been 100% clean and sober for over 5 years. while it wasnt easy, it's much easier than staying on these drugs and it's much less painful than a funeral. this "study" sucks and will bring many new addicts into the world. it's hard to face the world when you've gotten used to the false feel good feeling of an opiate. but it can be done. it's just a million times harder than if you just left it alone to begin with.
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