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Jul-29-2012 01:59printcomments

It's not all about 'Abuse' -- Let's tell it like it is -- It's 'Addiction' and pharma and the FDA is responsible for it

Part 1 of a series


(MYRTLE BEACH, SC) - Physicians for Responsible Opioid Prescribing (PROP) have filed a Citizens Petition to the FDA putting pressure on the agency to change the labeling of Opioids.

Before the pharmaceutical companies such as Purdue Pharma, maker of their lethal drug, OxyContin continue their marketing of the word "abuse", let's throw out the word "addiction" to them.  Opioids are not in short supply.  After all, they are manufactured in huge quantities to find their way onto the streets. Victims of Opioid addiction should consider receiving help as soon as possible. It only takes a few moments to find local rehabs in your area, so make the first step before you or a loved one’s addiction worsens.

The Drug Enforcement Agency (DEA), the Federal Drug Administration (FDA) and law enforcement agencies know this.  So in rides a professional organization called Physicians for Responsible Opioid Prescribing (PROP).  Their website is shown here:  They served the FDA with a Citizens Petition which I challenge the FDA to ignore -- as they have ignored the ever escalating deaths and addictions crippling this country and Canada.

Approximately 40 physicians, scientists and health officials filed a petition to the FDA this week requesting a label change be used on painkillers such as OxyContin and Vicodin. Many of the signers of the petition are connected with PROP, as well as the New York City Health Commissioner, the Cleveland Clinic, the Mayo Clinic, universities and Sidney Wolfe, M.D. watchdog group "Public Citizen". Dr. Wolfe has long been a nemesis of the FDA calling the agency out on dangerous drugs approved by the agency.

The Citizen Petition calls for changes to the labeling used on narcotic painkillers, which if approved, would make it more difficult for pharmaceutical companies to market the dangerous and addictive painkillers for chronic, noncancer pain. 

Now be ready for the pharmaceutical companies such as Purdue Pharma to use their scare tactics through the media, public relations filings, their lobbying pain societies financed by pharma to focus on the word "abuse" and to have people already over-prescribed drugs such as OxyContin by their physicians who do not know the long-term effects of opioid therapy to scream "foul" -- they need their opiates.

In reality, this prescription drug epidemic is about the word "addiction" and lots of it in every single state in the country. Patients are being prescribed painkillers in record numbers by their primary care physicians who were "educated" by the drug companies pushing the painkillers for every level of non-cancer pain. The objective of the Citizen Petition filed with the FDA is to help reduce the overprescribing and the volume of patients with chronic noncancer pain [CNCP] becoming "addicted" to dangerous painkillers.

Chronic Opioid Therapy (COT) has never been shown to be both safe and effective over the long-term for many patients, especially in higher dosages. I'll save those chronic non-cancer patients "hooked" on painkillers the trouble of sending long-winded, rambling emails to me -- there are no studies for long-term use -- the FDA knows it and so does pharma. Studies of the treatment of noncancer pain with opioids is less than 12 weeks.

This unprecedented move to hold the FDA to the fire by medical professionals and health institutions comes after a sharp rise over the past decade of death and addiction which many attribute to physicians over-prescribing dangerous painkillers as a result of pharmaceutical companies encouraging treatment of non-cancer, moderate pain with narcotics intended for severe pain.

In the past decade, prescriptions for opioids have increased four times resulting in an epidemic of opioid related deaths and patients seeking treatment for addiction. The FDA is being challenged in the petition to reduce harm caused by painkillers responsible for the soaring mortality figures in every state in the country.

The Citizen Petition calls to strike the word "moderate" from the label and to include a maximum of the equivalent of 100 mg a day of morphine and a time period of no more than 90 days when used to treat noncancer pain.

A Purdue spokesman, noting that opioid use and dosing has been on the FDA's radar over the past decade, said "FDA, its advisory committees, and numerous medical experts maintain that the current indications for long-acting opioids are appropriate. We agree with the FDA that prescribing information for any medication should be subject to ongoing review and modification to the extent that compelling medical evidence emerges."

I'll remind the Purdue "spokesman" that you and your pharmaceutical company lied about the dangers of OxyContin -- remember?

You convinced the medical profession when OxyContin was unleashed on the unsuspecting public that your drug was less likely to be addictive. You were charged with a felony and sentenced in Federal Court -- oh and pleaded guilty to the charges.

Your actions are the direct cause of this Citizen Petition which is making a valiant effort to save lives. It is too late for the tens of thousands of individuals who have died or are fighting addiction because of your marketing lies -- so save the public relations blitz using the word "abuse."

Tell it like it is and use the word "addicted" -- you are responsible for being evil and putting billions of dollars in your pockets at the cost of ruining countless lives in the U.S. and Canada.

OxyContin Victims

Public Citizen's Dr. Wolfe, said the next step is for the FDA to take action on the petition. He said they could simply grant the labeling changes or hold an advisory panel hearing on the issue. "They can't just write this off," he said.

If the agency does not take action in a reasonable amount of time, Public Citizen could take it to court to force a response, Dr. Wolfe said. May I suggest Dr. Wolfe bring Senator Charles Grassley of Iowa with him to court. Senator Grassley has been quoted as saying about the FDA "This is an agency that has gotten too big for its britches."

The FDA doesn't have their heads in the sand with the prescription drug epidemic -- they have their heads in the bank accounts of pharma and it's time for a massive withdrawal. Hopefully the Citizen Petition will snap Congress into investigating and demanding answers from the FDA about their lack of action in ending the prescription drug holocaust.

Next week -- Part 2 -- how many employees at the FDA approve dangerous drugs to be used on the American public and then leave the FDA to work for the pharmaceutical company whose drug they approved?

LP -- I thank God every day for the gift he has given us -- each other. I cherish you for what we bring to each other -- it's straight out "cosmo"

Marianne Skolek
Investigative Reporter for
Activist for Victims of OxyContin and Purdue Pharma - a criminally convicted pharmaceutical company

_______________________________________ Investigative 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.



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karen August 3, 2012 7:13 pm (Pacific time)

"and there are concerns that heroin use could rise,...", HEROIN USE HAS RISEN. It's a terror and OXYCONTIN HAS PAVED THE WAY.

DJ: Interesting observation, considering that heroin has been around and used for centuries before oxycontin.  

Mary August 3, 2012 11:22 am (Pacific time)

Wow! So now we've resorted to name calling, despite knowing nothing about a person at all. Because someone doesn't share your same views and agree with you, you must resort to childish tactics to make a point. This is what this country has become. I wonder, Ms. Skolek, how many cups of coffee and how many caffeinated drinks you consume a day? If you can't start your morning without at least 1 cup of coffee, you my friend are an addict: If you take ANY medication for high blood pressure, you face the risk of experiencing a multitude of reactions and symptoms including: constipation, diarrhea, irregular or very rapid heartbeat (palpitations), dizziness, lightheadedness, or weakness when standing up suddenly or getting up in the morning (from reduced blood pressure), drowsiness, dry mouth, fever, heartburn, stuffy nose, excessive hair growth, fluid retention, joint aches and pains, swelling around the eyes, cough, or rash. There is also a very real possibility that if you are elderly, you just might overdose on this medication and die - it happens all the time:  Perhaps you don't drink caffeinated beverages or take blood pressure medication. Perhaps you are much more content to sit around and smoke joints all day long. I don't know, but it is obvious that you are one of the lucky ones that can sit on your high horse and condemn those who need these medications for reasons that are totally beyond their control. I was born with my disease, I didn't have a choice - it's nice to know that there are people out there such as yourself who are far superior to the rest of us commoners, and are able to use attitude to put us in our place. Whatever would we do without you?

Editor: What is it that you are actually standing for?  Marianne is a nurse, she suffered a great loss in relation to OxyContin which was marketed to doctors initially as non-lethal and non-addictive.  You don't need to respect life if you don't want to, but any companies working in these areas must be held to the highest standards and they have to be logical, not profitable.  The latter dominates the entire program.  People aren't perfect, nobody claims to be; but you are attempting to demean one of the most knowledgeable writers in the nation and it looks like a big use of energy and little else.  

Marianne Skolek August 2, 2012 5:13 am (Pacific time)

Mary Maston -

You say "I don't deny that the pharmaceutical companies were pushing a personal agenda - after all, they are in business to make money, just as every business in the world is." No they are in the business to be truthful about the dangers of their drug and not lie to the medical profession about the addictive qualities of their lethal drug. About making money at the cost of human life? Makes me sick that anyone would make such a statement. As far as my daughter goes, this has long ago been about the tens of thousands of families lied to about opioids who have died and become addicted -- not about my daughter. When I read the ramblings in defense of taking quantities of opioids and having them accessible -- it sends a strong message and that message is addiction. I hope yours is the exception to the rule, but am not convinced.

Mary July 30, 2012 7:54 pm (Pacific time)

I suffer with the same condition that Nancy does - Medullary Sponge Kidney. I also happen to be an Advocate not only for MSK patients, but for chronic pain patients as well, because MSK is a chronic pain disease. Not only do I take a very low dose opiate medication, but I use heat, light exercise (because anything strenuous knocks stones loose and causes me to urinate blood for several days), and herbal therapy -not medical marijuana, which you seem to advocate heavily for and is just as controversial as opiate medications here in the south. It is illegal in the state of Florida. Before I was able to find a doctor to treat me, I was completely bedridden because of my disease. Now that I'm taking medication, I can actually be productive. I was born with this disease and it is progressive, meaning it will continue to get worse over time. I went through 4 surgeries last year, and have had a total of 11 surgeries since the age of 13. I was also in the emergency room 5 times last year because my pain was totally out of control. Several times my husband had to literally carry me to the car to get me to the hospital because I couldn't walk on my own. I am not a drug addict and have no desire to become one. I use my medication responsibly the way that I'm supposed to. I work closely with my doctor and follow his orders to the letter. I keep my medications locked in a fire safe box so that my children do not have access to them. I do everything I'm supposed to do, the way I'm supposed to do it, and I am STILL treated like a common criminal every single month when I try to get my prescription filled. You claim "Nobody wants to deny people with such pronounced cases meds that work, that is not the point at all." Yet, you support the proposal of PROP to limit the dosage of opiate medications to 100mg per day, with a 90 day maximum limit, except for people who have cancer. What happens when that 90 day limit is reached for someone who doesn't have cancer? Ironically, I have yet to see an answer to that question. I was born with this disease, it is progressing every second of the day, and I will die with this disease. There are other horrible diseases and circumstances besides cancer that cause chronic pain. God forbid you end up in a horrible car accident, or have a limb crushed in a horrific workplace accident, or are diagnosed with Fibromyalgia or MS, or rheumatoid arthritis. After your 90 day treatment period with opiates, you just have to suck it up. Empathy and compassion no longer exist in this country. They have been replaced by personal agendas and witch hunts. I'm very sorry you lost your daughter - I wouldn't wish that on anyone, but people can overdose and die on Tylenol; people can overdose and die from water intoxication; people do die every single year because they eat themselves to death - let's ban Tylenol, drinking water, and why not - let's ban food too why we're at it. Toothpaste can be toxic if you eat an entire tube of it. Breathing can kill you too, with all the toxins and pollutants in the air, are we going to ban that too? There is no common sense to what PROP is suggesting. Can you honestly tell me that the entire chronic pain population, all 100 million U.S. citizens strong are addicts? That's a third of the 314,059,775 people in the United States. Really? If that is the case, then how are businesses functioning - from McDonalds to the White House? If everybody's an addict and so busy looking to score their drugs, why hasn't the entire nation come to a complete standstill? If we are all addicts and doped up, how on earth are we able to respond to your article and even form coherent sentences? I don't deny that the pharmaceutical companies were pushing a personal agenda - after all, they are in business to make money, just as every business in the world is. Everyone says that no long term studies on the effects of opiates have been performed - so why don't we look at doing that first, before condemning the patients that need these medications to a life of pure torture and hell and banning all opiate medications? Let's use some common sense here; we are an intelligent nation - let's put that intelligence to use and look at all the options before jumping the gun and making a decision that's going to cause more harm than good.

Mary Maston
MSK Advocate

Editor: We do not have to agree, you have made your point, and I appreciate the fact that you use a first and last name.  Again, out writer has only the best intent.

Nancy July 30, 2012 1:56 pm (Pacific time)

These doctors should try to pass kidney stones several times a week without opioid pain medicine. I have a congenital birth defect, called Medullary Sponge Kidney. The side effect of this is Nephrocalcinosis. To explain, (Nephro-kidney Calcinosis- calcium) - I have calcified kidneys. My kidneys are full of THOUSANDS of small kidney stones in the meat of my kidney. These stones work their way out, crystalize, and grow bigger. I pass small stones every day and large stones regularly. I used to have to go to the ER whenever my pain was intense. My urologist gave me an opioid Rx to control my pain at home. For the last 3 years, he has given me up to 120 pills and they last me about a year. I try to manage my pain with a heating pad and lots of water. I am careful about what I eat. Medical Marijuana is not legal in Florida and I am not willing to break the law. If it becomes legal I will try it, but my urologist does not think it will help with the intensity of pain I have.
I had a very hard time filling my last Rx. I had to go to several pharmacies. The pharmacy I had been going to for years said they were out. I heard the same story from pharmacy after pharmacy. I finally found an independent pharmacy that filled it for me.
There is a non-narcotic pain reliever called SPRIX that works very well for me. It can only be used for 5 days and is very hard on the stomach and kidneys. I use that as much as I can, but most of the time, for the health of my kidneys, I cannot take it. I do use other remedies: heat, diet, meditation, deep breathing. Sometimes nothing helps except a narcotic.
I am getting worse every year. Since 2004, I have surgery to remove kidney stones on average 1-2 times a year. I had a 7mm stone stuck in my ureter for 5 months. I had to take daily opiates during that time period. I thought I would end up dependent on the drug, but when I healed from the surgery, I had no problem stopping the drug.
There are many legitimate patients that need opioid pain relief that do not have cancer. We should not be left to suffer just because of abusers. Abusers make the choice to break the law. Why should I suffer because they might end up dead? Spend more money on drug prevention training, rehabilitation, police enforcement and tougher judges sentencing to prison terms that will scare potential criminals to not start abusing drugs in the first place.
Do not deprive legitimate patients of the medication they need.

Editor: Nancy, the goal is to force responsibility, nobody wants to deny people with such pronounced cases meds that work, that is not the point at all.  And I agree, medical marijuana may make it easier to deal with, but it would not serve as a complete pain remedy.  It is too bad you live in that state, no marijuana and they will charge you with a felony for photographing a farm field.  I wish you the best. 

Terry July 30, 2012 11:10 am (Pacific time)

I am with all of you.I to take pain meds.Not because I want to but because I have no choice.It's that or spend what time I have left laying on my back.I worked all my life , paid taxes and raised a family.I have a right to get my pain meds so I can enjoy my grand children before it's my time to go.I don't beleive the government that I have supported for the past50 years has the right to take that away

Editor: Nobody is trying to stop legitimate chronic pain patients from having relief, but I hope you realize that most of man's time on earth has not involved pills to make you feel better when you suffer from pain.  We can take this many directions; people don't try natural remedies, sometimes it is illegal, but for anyone to allow this stuff to rule their life is just sad.

Elinor July 30, 2012 10:09 am (Pacific time)

The FDA is NOT RESPONSIBLE for what people do with their lives.

 Editor: Another apologist for big pharma?  What could you possibly mean... people are guided by this agency, that assertion is one of the most ridiculous yet.

My heart breaks for all those whose who were victim due to their bad choices, and taking medicines beyond dosages allowed or legal, for that matter. I myself have lost people to drug overdoses, so I am an advocate all the way around. I AM ALSO A PAIN PATIENT .. With the DAMAGES THE DEA HAS DONE ALREADY IN THIS WAR ON PRESCRIPTION DRUGS .. is DOWNRIGHT UNCONSTITUTIONAL .. and people are suffering beyond your wildest imaginations.

 Editor: I can hear you weeping from here, but do you realize that many die from this drug without it even being an overdose?  This stuff kills people and doctors and a sundry group that includes you, are the saddest examples of all, it is always either addiction or profits that drive these false allegations.

You have no idea ( if you are not a pain patient ) what it is like to not be able to get your medicines in order to work, take care of your family or just plain ... get out of bed each day. So many people are suffering and WE ARE the Collateral Damages .. suffering such HORRIBLE FATES. How about you or someone you love so dearly ..... suffering with insurmountable pain, everyday beyond anything you could imagine.. and BECAUSE OF ADDICTS, DEALERS AND/OR CRIMINALISTIC BEHAVIOR OF OUR PROFESSIONALS..

 Editor: At least they are still alive, more than many can say.

The rest are forced to suffer like this ?? WRONG ON ALL COUNTS... WE ARE NOT ADDICTS, WE ARE NOT ADDICTED .. WE ARE SIMPLY PEOPLE WHO HAVE BEEN HANDED CRUEL FATES AND ARE NOW BEING FORCED TO SUFFER FURTHER ... FOR SOMETHING SO HORRIFIC AND UNDESERVED, IT IS NOT THE AMERICAN WAY .... OUR CONSTITUTIONAL RIGHTS HAVE BEEN VIOLATED... WE CAN NOT EVEN GET OUR MEDICINES FILLED ANYMORE DUE TO THE DEA and THEIR GOD-AWFUL CARTEL TACTICS .. INSTILLING FEAR IN OUR GOOD DR'S and PHARMACISTS... THIS IS A SAD TIME IN THIS COUNTRY ... Where Innocent people of Pain are committing suicide now because they can not get their medicine prescriptions filled, being profiled and kicked out of Pharmacies .. Plain out lied to, denying our rights as American Citizens to medicine. S A D !!!!!!!!!!

 Editor: Ever try medical marijuana?  Ie has never killed anyone.


Editor: The FDA is responsible in this area, the DMV oversees car operation and drivers licenses; the EPA takes care of the environment.  You can't say the FDA is not responsible because they are and the question is whether they are living up to that responsibility or simply lining their pockets. 

Teresa July 29, 2012 2:07 pm (Pacific time)

Do you understand what you are doing to those of us out here who AREN'T addicts????? We are having a hard enough time without something like this going on!

Florida Pain Patient July 29, 2012 6:07 am (Pacific time)

"Central Florida physicians are prescribing less oxycodone now than in the past, partly because they're now being tracked by the Prescription Drug Monitoring Program. Some local pharmacists also are reluctant to fill prescriptions they think might be suspect. That means abusers are turning to other drugs, such as the painkiller hydromorphone, investigators say. And there are concerns across the country that heroin use could rise, and that overdoses could increase as abusers try drugs they aren't familiar with. In Seminole County, narcotics investigators say they are seeing more hydromorphone on the streets, but it's not because that is the preferred drug. "It is because it is cheaper and easier to acquire than oxycodone," said Sheriff's Office spokeswoman Heather Smith.

Florida Pain Patient July 29, 2012 5:41 am (Pacific time)

I am on your side and live here in Florida where I see the rampant "pill mills" popping up and the associated "pain customers" lining up in the morning before opening time. However, I am also a disabled veteran who is in chronic pain and have been using low-dose narcotic pain pills for 15 years. I can't understand how chronic pain patients are being prescribed high-dose medicines, as I am good on a mere 5 mg. dose. My doctors have indicated that the intent is to keep the dose at the absolute lowest level possible in order to combat tolerance forming. They made it clear that the use of narcotics is not to alleviate ALL the possible pain and that is not the intent; the use is so that I can have a reasonable quality of life and not be confined to a bed. I had undergone several painful pain-related surgical alternatives until there was nothing else to try. I destroyed my gut using other pain medicines that were ineffective. I am completely on your side and hope that everything is done to keep these drugs from being abused. But there are doctors who are now afraid to even consider these drugs for patients who really need them. There are stories here in Florida of pharmacies that are too afraid to even take on new pain customers because the DEA is swarming down here. While I support your fight, until there are other alternatives that work, narcotic prescriptions cannot be simply written off. Would marijuana help? I don't know, but it is not even an option...

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Sean Flynn was a photojournalist in Vietnam, taken captive in 1970 in Cambodia and never seen again.