The Convicted Criminals Have Reformulated OxyContin, But is it Safer?

The United States has been involved in this epidemic of OxyContin addiction, abuse and death for well over a decade now.

(MYRTLE BEACH, S.C.) - Last week I was invited by the FDA to participate in a teleconference on the reformulation of the drug, OxyContin.

The teleconference began with Bob Rappaport, M.D. giving a brief talk on the reformulated drug. Dr. Rappaport is the director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.

He was quoted as saying "Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction. As with all opioids, safety is an important consideration.

Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."

The Food and Drug Administration has approved this new oxycodone formula; which releases the drug more slowly into the system OxyContin can be broken down, crushed, heated or dissolved and used by drug abusers for its opioid pain killer properties. The new formulation is released over the course of a day to “discourage misuse and abuse of the medication” says the FDA in a news release.

The FDA warns the drug can still be abused by taking larger quantities than recommended.

Manufacturer, Purdue Pharma of Stamford, Connecticut submitted the new formulation to the FDA for review in September 2009. Purdue Pharma must conduct post marketing evaluation of the new formula to determine if the reformulation has resulted in less use by abusers.

When the presentation by Dr. Rappaport was completed and comments were offered by those invited to participate in the teleconference, I indicated that I had a comment and in short time, I was called upon and below is a synopsis of what I said.

I don't have to tell the FDA that the United States has been involved in this epidemic of OxyContin addiction, abuse and death for well over a decade now. The reformulation of OxyContin is too little, too late for the victims of this drug. The FDA has indicated that Purdue Pharma will be required to conduct a postmarket study to collect data on the extent to which this new formulation reduces abuse and misuse of OxyContin, as well as a Risk Evaluation and Mitigation Strategy regarding the appropriate use of OxyContin in the treatment of pain. That is my concern. I wouldn't believe any study conducted by Purdue Pharma. How is the FDA going to safeguard that the data submitted by Purdue Pharma is not slanted and is accurate? I am going to make a recommendation to the FDA today -- and will be working with them diligently -- that OxyContin be reclassified immediately for severe pain only -- and the labeling changed to reflect that it is not to be prescribed for moderate pain. This company cannot be allowed to further ruin the lives of scores of innocent victims under the watch of the FDA.

In the meantime, Purdue Pharma posted the below release on their website regarding the reformulation of OxyContin. My problem with this press release is the line "Purdue elected to reformulate OxyContin® to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction."

So in Purdue Pharma's words, if there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction -- what was reformulated?

My guess is that the gatekeeper at Purdue Pharma, J. David Haddox, dentist turned psychiatrist and currently Vice President, Risk Management & Health Policy will be involved in the post marketing data submitted to the FDA on this new reformulated OxyContin.

Since I wouldn't believe anything Haddox says -- even if his tongue were notarized, I will be closely following the data submitted to the FDA by Purdue Pharma on the reformulated OxyContin.

STATEMENT OF PURDUE PHARMA L.P. REGARDING FDA'S APPROVAL OF REFORMULATED OXYCONTIN^® (OXYCODONE HCl CONTROLLED-RELEASE) TABLETS

April 5, 2010 - The U.S. Food and Drug Administration (FDA) approved Purdue Pharma L.P.'s New Drug Application for a reformulation of OxyContin^® (oxycodone HCl controlled-release) Tablets.

The reformulation has met FDA criteria for bioequivalence to the original formulation, which means there is no significant difference in the rate and extent of absorption of the therapeutic ingredient.

While similar in appearance to the original formulation, the reformulated tablets have a different marking ("OP") than the currently marketed tablets (marking "OC") and the 60 mg and 80 mg tablets are slightly larger in size than the currently marketed tablets.

Purdue elected to reformulate OxyContin^® to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction.

OxyContin^® continues to be a CII controlled substance with all the attendant risks of Schedule II opioids, specifically that the drug has a high potential for abuse. Use, misuse, or abuse of the drug may lead to physical dependence or addiction (addiction is sometimes referred to as "psychological dependence"). In addition, alteration of the tablet in any manner poses significant risks of overdose and death. The Full Prescribing Information contains warnings about the potential for abuse, diversion, overdose and addiction, including a boxed warning (see below).

Indications and Usage
OxyContin^® is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

OxyContin^® is not intended for use on an as-needed basis.

As used here, "moderate" and "moderate to severe" pain do not include commonplace and ordinary aches and pains, pulled muscles, cramps, sprains, or similar discomfort.

OxyContin^® is not indicated for the management of pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin^® is indicated for postoperative use following the immediate post-operative period only if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

OxyContin^® is not indicated for pre-emptive analgesia (preoperative administration for the management of postoperative pain).

OxyContin^® is not indicated for rectal administration.

Important Safety Information
OxyContin^® is contraindicated in patients who have significant respiratory depression, patients who have or are suspected of having paralytic ileus, patients who have acute or severe bronchial asthma, and patients who have known hypersensitivity to any of its components or the active ingredient, oxycodone.

Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Use low initial doses of OxyContin^® in patients who are not already opioid-tolerant, especially those who are receiving concurrent treatment with muscle relaxants, sedatives, or other CNS active medications.

Serious adverse reactions which may be associated with OxyContin^® Tablet therapy in clinical use are respiratory depression, apnea, respiratory arrest, and circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

REMS
Working with the FDA, Purdue has developed a Risk Evaluation and Mitigation Strategy (REMS) for OxyContin^® Tablets. The OxyContin REMS includes a Medication Guide, Elements to Assure Safe Use, such as healthcare provider training and a timetable for submitting assessments of the REMS.

Product Shipment
The Company expects to begin shipping all dosage strengths of the reformulated product (10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg) to distributors and pharmacies during the third quarter of 2010, at which time Purdue will cease shipping the original formulation.

"We will work with distributors and pharmacies for a smooth transition to the reformulation that will maintain product supply and protect patient access," said John H. Stewart, President and CEO of Purdue Pharma L.P.

About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

The professional product labeling for OxyContin^® Tablets contains the following boxed warning:

WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR ABUSEOxyContin contains oxycodone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. (9)

OxyContin can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. (9.2)

OxyContin is a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. (1)

OxyContin is not intended for use on an as-needed basis. (1)

Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients, as they may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory-depressant or sedating effects of opioids. (2.7)

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. (2.2)

OxyContin must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. (2.1)

The concomitant use of OxyContin with all cytochrome P450 3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir) may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse effects and may cause potentially fatal respiratory depression. Patients receiving OxyContin and a CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (7.2).

Full prescribing information for OxyContin is available at
http://www.purduepharma.com/pressroom/news/OxycontinPI.pdf.

Contact:
James Heins
203-588-8069 (Office)
203-856-2121 (Cell)
James.Heins@pharma.com

Libby Holman
203-588-7670 (Office)
203-609-1291 (Mobile)
Libby.Holman@pharma.com

_________________________________

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 Writer, Salem-News.com

www.purduepharma.com/pressroom/app/news_announc/USGovt_reponse_Main.pdf

judiciary.senate.gov/hearings/testimony.cfm?id=2905&wit_id=6612

i.bnet.com/blogs/sebelius-response.pdf

www.vawd.uscourts.gov/PurdueFrederickCo/default.asp

www.oxydeaths.com

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Crowley November 14, 2016 10:41 pm (Pacific time)

Either you are willfully ignorant or uninformed, the only epidemic we are facing is prohibition. Legalize oxycontin for recreational use and let people be responsible for their own lives. Eliminate the bottleneck on production and distribution of just this one substance, and your drug hysteria can finally die a long overdue death. You fools have had over 40 years to prove you were wrong. Step aside it is time for reason and reality.

Socialists June 3, 2012 7:06 am (Pacific time)

I love the description of Jill in the prologue "died after having been prescribed OxyContin." Sort of like saying died after having bought a car. Does not go on to say after having 6 drinks , getting into said car and driving into tree. Take some responsibility for your own life.

Editor: Right, and if I were allowed by the government to take the brakes off that same car you were buying, but still tell you they were on, then you would have an accurate comparative analogy, as it stands you do not, you are talking apples and elephants. Plus, you are just an insensitive ass, that is painfully obvious. The woman you reference died from an Oxycontin-related respiratory failure, she was not an addict and never had been. It just killed her. Good luck managing your addiction, I reckon it is a pathetic existence based on your cruel and insensitive remarks about our writer's late daughter, jerk.

Paul March 3, 2011 11:50 am (Pacific time)

I've used this and other opiates correctly for over 10 years now. I have chronic pain due to MS and L5S1 herniation. I can't even take my prescribed amount due to GI upset and constipation. I have no idea how anybody can get addicted to this junk without puking their brains out, all it does to me (in addition to pain relief) is make me nauseous, itchy and "blocked" up. Why someone can take these drugs (opiates) to get high is beyone me.

Oscar Contin January 7, 2011 7:13 pm (Pacific time)

I Miss the old ones.... I dont care about being a junkie I wish I had enough to last me the rest of my life. I dont drink, smoke (weed or butts) or consume any other drugs or narcotics. I have never even tried Heroin.... I was prescribed OC-10's after a rotator cuff surgery and I fell in love . The new OP's still work you just have to be creative. for one if you grind up the pills coating an all and let it soak all night in a shot glass full of coca- cola the opiate will be released into the soda and in the morning do the shot and you will be wasted....No BS Next grind it up coating and all the microwave it on a dinner plate for about 5 min when it starts to turn a creamy bone white color scrape it up with a razor blade the consistency will be like melter chocalate ball it up and then out it in the freezer until it hardens 10 min usually.... the use a ped Egg to grind up one more time snort and you will feel the affects within minutes... I really dont care abiout the dangers. I mean who the hell wants to live in the world Obama wants to create...I would rather be high til I die hang on and enjoy the ride...I makes no difference to me everyone is addicted to something. I choose beans.... and if you look hard enough the real ones are still out there thank good its like Christmas once a month when they arrive....millions of dollars in RandD to curb misuse and a 2 dollar idea to get a similar high as the old ones.... just bring them back Purdue.... who cares you were making millions make you money and hook us up....bring them back like Coke did. you can call it Oxy Contin Classic...or sell the recipe to a cartel so they can make it so we can have them for ever snortin the roxies are killing my nose.... I go through so much Afrin I need to buy stock in the company.

daddio December 13, 2010 3:48 pm (Pacific time)

step up to the plate you wimpy americans! we are sick of your crap!

heroin addict November 19, 2010 10:39 pm (Pacific time)

To everyone saying this pill helps with pain... this is rediculous. opiates do not help pain for a dam. take ib profen. seriously the original oxys are exactly the same buzz as heroin and you can melt them like butter and inject them. idc if you take them for pain, you are still addicted to a drug exactly like heroin. when you take the same amount day in and day out eventually it does nothing but keep you normal. you would have much less pain if you never took these in the first place. the increased pain you feel now is the withdrawls. Long story short you are a bunch of legal junkies whining about your dope being takin away. if you want the "pain" relieving qualitys of the old oxys go to the inner city and cop some heroin. the only pain these help with are emotional pain and pain from withdrawls. the old oxys have taken away the stigma related to heroin and created a ton of 20 yr old heroin addicts.

David November 11, 2010 8:24 am (Pacific time)

I have been taking this drug and using it properly for iver 4 years now, due to neck injuries from flying through a windshield and landing head first in a huge boulder to boot. It crushed 2 cervical dics, one of which is ont the berge of herniation. It took a few years after this accident for the effects to become a problem, and I do NOT want to have the surgical fusion recommended by the neurosurgeon. Out of three people I know that have had this surgery, one was helped very mych, one was no different at all, and one is now paraplegic, and still in pain chronically. Oxycontin was a true blessing for me, taking three 30 mg. pills a day made my life almost entirely normal. After 2 months on the reformulated version, I can testify that it does NOT provide the same amount of relief. I only wish that some people from Purdue Pharma would have to walk a day in my shoes. All the media hype leaves out the fact that of all the overdoes deaths, there are multiple other drugs in these peoples bloodstreams. My very own son had some "friends" from Miami that used to come over once in a while, and they always gave him a handful of these, claiming it was very easy to obtain legally. One day I came home from work, only to find him lying in a pile on the litchen floor, with some oils around him (80 mg). But the tox screen from the ME showed he also had a high amount of xanax and nethadone in is blood, simultaneously. C.O.D. was shown as poly drug abuse, not oxycontin overdose. I called 911, and gave him cpr and mouth to mouth until they arrived, but he died right there in my arms, with his eyes open, and I'll never get that image out of my mind! Though they did their best, he had died before they arrived, and there was not a thing they could do. I still take 3 20 mg pills a day trying to live a pain free life, as much as possible, but nothing can completely alleviate nerve pain. The stearoid injections do stop the pain enturely, for about 3 days, and you can only have so many per year, and they do hurt like hell when they hit the spot, so I hate them. All of this tells me there are a combination of bad doctors, and abusive users, a deadly combination. Can you imagine a clinic that accepts cash only, and has their own pharmacy on site which dispenses these drugs, again cash only, no insurance accepted! Talk about a conflict of interest!!! How is it that these types of clinics are allowed to become licensed? I've even heard they have "bouncers" in the doorway, who will only admit people that show their appointment slips. There are stories of lines around the block, and many robberies in the parking areas adjacent to these types of clinics. None of these are verifiable, but it tempts me to make the three hour drive to the other coast of Florida to see if it is true. This new fornulation does not provide anywhere near the same amount of pain relief, and I can already see the lawsuit that will result. As soon as the patent on the original formula runs out, there will no doubt be plenty of companies who will jump on the "moneywagon". This was the absolute dumbest kneejerk reaction to a problem that I can imagine, and it will only pusg the serious abusers into the heroin market. We shall see, we shall see....

John Franklin October 31, 2010 10:33 pm (Pacific time)

I suffer from sickle cell anemia I have chronic pain everyday and take oxycontin It takes the new ones way to long to start to ease my pain.I think that people that suffer from chronic pain should still be able to receive the old oxycontin if that what helps best. the people that made these changes need to walk in our shoes just for a few minutes then they will see what we as chronic pain suffers go threw

Steve October 25, 2010 2:01 pm (Pacific time)

I suffered a tradigic bicycling accident 3 years ago and tried a number of different pain meds. Vicodan was absolutely the worst and may have cost my company the Home Depot account as I had a violent and angry reaction to the drug when speaking to the buyer....I suffered rashes and was unable to function normally with Hydrocodone due to pain and fatigue. Oxy was a blessing. I put my cane away 6 months ago....I am permanently disabled and in constant pain much of the time. Oxy gave me my life back. The new formula does work but much more slowly and the lift that allowed me to spend evenings working or socializing is now gone. The cane may be coming back especially in the evenings. I hate drug abusers for destroying what was a very helpful attribute of the drug. I don't know what caused the lift and I'm sure that that is why it was so much fun to abuse. I do think that the pain reduction is close but not quite the same and the lift is something I do miss. It was a nice counter balance to the lethargy that comes with pain killers and with chronic pain. I hope that someone comes out with a pain killer that does the same thing that the old Oxy formula did in terms of the lift and increased energy...

sandpark40 October 16, 2010 9:00 pm (Pacific time)

I am so angry right now I am a nurse for over 30 years 15 of those years in hospice so i do know a little about effective pain control. about 15 years ago was diagnosed with fibromyalgia and just recently was put on oxycontin and oh my god what a difference it made from my personal life, to my job. It was like someone gave me a new release on life so when i just recently picked up my meds for the month and saw the difference in appearance starting questioning what was happening symptons pulse at resting was 120, nausea dizziness, ringing in my ears,chest pain and sob and image my surprise when in got on line i honestly don't know what i can do about it to get that feeling back that all was right in the world and i was no longer a slave to my pain

Jason October 14, 2010 12:26 pm (Pacific time)

Alex is the first person to hit the nail on the head, the patent is about to run out and Purue wants to keep the market on their golden goose which draws in over a billion dollars a year, so they simply reformulate it and bingo they have the market for another 14 years, they care nothing about people abusing the drug, just watch and see how fast they go back to the old formula when people quit using the new ones and they start loosing money.

raymond October 10, 2010 12:39 pm (Pacific time)

I think we need less people poking their nose in other people's business, and if somebody wants to abuse oxycontin, get stoned or just have a death wish, then they should be allowed to do as they wish, after all it is their bodies and mind not yours. So this message is to all you anal doctors, administrators, government officials and so on and so forth BUD OUT. No body asked for your help, nobody wants your help and it is non of your business if somebody wants to abuse any kind of drug. Not everybody wants to be straight all the time like the rest of you morons.

Nate October 7, 2010 12:44 pm (Pacific time)

After serious helth issues, I've been taking Oxycontin for about 4 years now. I'm not a drug abuser and taken as directed, the old OC was truely a miracle. The true CP patients out there understand this all too well. After taking the op for 3 days, I don't have the same pain control, upset stomach and headaches. This OP formulation is not the same. If Purdue and the FDA were responsible, the proper studies should have been conducted to determine the risks and benefits for the CP patient and the drug abuser. It seems very conclusive from on-line chats that addicts already discovered successful methods for tampering. This is unfair to the CP patient and quite typical of US Government and business. Understood, Oxycontin is a dangerous drug and deaths are indeed tragic, something has to be done BUT it should not be to the expense of the CP patient. Job well done Purdue-FDA...you accomplished your mission!

Lacey October 4, 2010 3:06 am (Pacific time)

I think it is about time they came out with something like the new oxcotin pill. Now it is slowly beging to make people relized that meds, are for treating pain. Not to get abuse. Maybe people will stop trying to abuse and use it like it should be used!!

richard September 30, 2010 4:42 am (Pacific time)

I believe that the new oxy really sucks and that the responsible people who esed will be going through hell.Most people who have drs. will say that it is all in their head about it not working, but believe me the drs. are so wrong.think of the ingredients in the pill itself rubber we are injesting,not me thanks.Down the road people who continue to use it will aquire serious side effects and then there will be law suits up purdues asses,OH WELL GOOD YOU IDIOTS AND THE ONES ATHAT ABUSE IT WILL TURN TO HEROIN AND THAT WILL CREATE MORE CASES OF HIV AIDS AND HEP C.GOOD LUCK TO ALL

Andrew September 30, 2010 12:21 pm (Pacific time)

This is ludicrous! Where's the reformulation for alcohol? Cigarettes? While we're at it we might as well reformulate motor oil and gasoline! I can't beleive a pharmaceudical corporation could actually be convicted for deaths based on an individuals recalcitrant behavior pertaining to this drugs use. This absolutely boggles my mind. It is not the fault of the corporations at all. How our society divides blame is outrageous. Blame the doctors, or more so: blame the patients! It's common sense (which I will never tire of saying is not that common) that cigarettes are addictive, alcohol can generate dependency and death and guns kill people, right? WRONG- the manufacturers slide by on the very same principle: it is the CONSUMER that allows those statistics to ring true. DUH, double duh, wake up America...

kristina September 23, 2010 6:44 pm (Pacific time)

I've been on oxycontin since april, and this is the 1st month I recieved the new formula and since I got it on the 11th I've been nausuated and usualy throw-up a few mins after I take the new pill!!! I never did that b4. I was actual out of pain for the first time in 3yrs!! Now I find my self needing more than 30mg twice a day. This new formual is not as strong and it also gives me migrains!! I cant wait to go to my dr and get off this crap and try something eles!!

JMARLOWE September 21, 2010 11:26 am (Pacific time)

I HAVE TAKEN OXYCONTIN SINCE 1996. IT WAS A REALLY GOOD DRUG WHEN IT FIRST CAME OUT. PURDUE HAS BEEN DOING TO IT FOR THE LAST TEN YEARS. MY HUSBAND READ AN ARTICLE IN THE READES DIGEST ABOUT THE DEA AND THE FDA DOING THINGS TO DRUGS WITH A TEN YEAR PLAN. WE HAVE NEVER BEEN ABLE TO FIND THE ARTICLE SINCE. THE NEW DRUG IS TERRIBLE. IT TAKES SO LONG TO TAKE EFECT. I STAY IN CHRONIC PAIN ALL DAY. MY HUSBAND AND MYSELF HAVE CHRONIC PAIN. HE WORKS A HARD CONSTRUCTION JOB AND I RUN A SMALL HVAC COMPANY. IT'S VERY HARD TO KEEP WORKING. THEY DON'T CARD ABOUT THE PEOPLE WITH CHRONIC PAIN. I'M SICK OF IT.

Peter G. September 19, 2010 11:48 pm (Pacific time)

Reply to: Editor on May 24, 2010 10:49 pm (pacific) I think you said it all there: "The biggest problem is that this is a deadly drug if used incorrectly." "If used incorrectly." What about the millions of people that use the drug correctly? We make them suffer so we can try and control an addict's behavior? So the addict moves to heroin, or takes larger, possibly fatal doses to achieve a high. What do you do now to fix that? I am truly sorry for the loss of this reporter's daughter. I just wonder why we can't we look at personal responsibility? Not that it was her daughters fault. There can be many reasons such as a doctor improperly prescribing, eg: keeping improper records, starting a patient that's not opioid tolerant on a high dose, etc. Are we sure that this is not a mission against a successful company that developed a very potent, and also highly addictive pain medication, that also allows millions of people, myself included to live at least half of a normal life. I think this reporter should look at thing's from the other side too. My life was ruined at the age of 20 in a car accident. Most everything that I wanted to do with my life, my career choices and alot of other thing's were lost for me. Obviously, the benifits of this drug outweigh the risks for me, as well as for MANY other people. I know this provides no comfort for this author, as her daughter lost all hopes and dreams in this tragedy. I think this has alot to due with a negative opinion of the capitalist system in motion. A company develops a drug, while dangerous, is so effective, it is one of the most highly prescribed (legally) for moderate to severe pain. (yes, for moderate pain too as people develop a tolerance to opiates, and eventually the acetaminophen in other pain killers will kill you just the same.) So this company makes alot of money because they make one of the most effective pain killers. Then someone dies and we imagine a greedy company raking in money hand over fist and not caring about their patients. So the lawsuits come out, and the lawyers, and they pick apart the wording on the prescribing label, and the FDA gets involved. I'm sorry but so many tragedy's happen every day to so many people that don't deserve it. These are narcotics that are very dangerous. These thing's that are happening with Purdue just defeat the purpose of the medicine. If a person wants to be an addict, YOU CAN'T CHANGE THAT! The only thing you can do is increase the chances that they die because of their bad decisions. Is that worth it? And who ultimately pays the price? People like me and millions more with a legitimate need, also, people that die because of other failures in the system like we see here. When everything else in the system works, there should be very few deaths on this drug. Can't we apply all this time and money on those things instead of a company that makes a product, which was good, that millions depend on. Now people like me have carcinogens, many other chemicals, and lowered effectiveness to deal with. I can't believe the FDA would do this to so many patients. I also hear (don't know if it's rumor or fact) that Canada won't even sell this formulation because of the chemicals. What is wrong with the FDA in America? Is it money? politics? I really wish I knew, but I just want to live in a pain free world.

Sammy September 18, 2010 9:35 am (Pacific time)

I am trying the new pill and I can say that it takes over 1 hour and 40 minutes brfore I have some leg abd back pain relief. compared to the original pill which gives me relief within 15-30 minutes. This new pill sux..and Purdue Pharma has found a way to increase there sales by having the consumer take double and triple doses of there new pill which will eventually lead to Overdoseing by the patients and where will Purdue Pharma be then? I see a LAWSUIT

russell September 16, 2010 12:47 pm (Pacific time)

i have i.t.p. will this new pill of oc hurt my platlets make them go down

helpless1 September 16, 2010 7:23 pm (Pacific time)

There was a time when I could get out of bed and go about a normal work day while taking oxycontin 80 3x a day for my chronic pain and now there is absolutely no relief at all from this new formulation, it does nothing at all and I'm almst positive that unless Perdue comes back with the old formula I'll be back to square one and be willing to try anything else that can provide me with a nearly pain free day because this drug sucks and is worthless to me right about now.

susan55 September 16, 2010 7:09 pm (Pacific time)

I am in cronic pain on a daily basis due to diabetic neuropathy and do not wealk or go about my daily routine unless my pain is under control and with this new formulation it seems like I'm not even getting the slightest bit of relief.This isn't fair at all for thosre of usthat do not abuse this drug in any way shape or form and I am pleading with this particular manufacturer to please go back to the old oxycontin formula so I don't become a vegetable and unable to even walk to the bathroom.FOR GOD SAKES PLEASE!!!!1

TO: Beth September 13, 2010 6:20 am (Pacific time)

Vicodin?? LOL

TO: House September 13, 2010 6:18 am (Pacific time)

I say this ALL the time, but alchol seems to be the politicians drug of choice--so let's just make the pain sufferer's life a living hell!! THE NEW formula can't as easily be abused, I aggree (this article's author is stupid), but it takes for ever to get into the system to get proper pain control. I'm MOVING to something else as soon as I see my doctor again!!!!

Josh Licata September 12, 2010 10:57 pm (Pacific time)

WHAT EVER HAPPENED TO PERSONAL RESPONSIBILITY? Its not the purdues fault people abuse drugs, they cant control this, unless they come out with a pill that. Everyone is pointing fingers for blame of people abusing drugs, but when it comes down to it, its no bodies fault except the one whos abusing the drug, using it as not what its intended for. yet no one can just take personal responsibility. whats next? Blaming a knife corporation, for a murder, just because someone killed someone with their knife? and say its their fault because the knife was just to sharp. well all of this is ridiculous and a broken society, where no one can take personal responsibility will be the result, if we keep doing this.

Editor: Illegal false marketing changes it quite a bit, and that is Purdue's story

Oxy User September 9, 2010 10:43 pm (Pacific time)

I have been properly using my prescribed Oxycontin for 8 years. When there were generics available some worked similar and some had nothing close to the same relief. The problem was that you cant return or exchange the medication until you have it and it is too late. The same thing appears to be happening with this new reformulation I have just picked up from the pharmacy. I checked it out to see what differences I could see, that is something I have not seen anywhere, just what the differences are, what have they done in an attempt to make it less able to be abused? As far as I can tell the coating on the outside of the pill has become more difficult to easily remove and the pill inside seems to be "glued together" or bound in a more thorough fashion thus making it more difficult to remove the coating and crush it up defeating the time release function and making it far less effective for those who wish to crush the pill and snort it thus giving a strong immediate high, I do not do this myself but those I know that abuse this drug do it in this fashion by snorting it. So yes it is going to be more difficult for those people to get high by snorting the ground powder from the pill and my guess is that this will lead to the person increasing the amount they snort. I believe this is going to be even more dangerous for those abusers however because to get the same effect they are going to be snorting much greater dosages in seeking to get the same effect which will lead to their ingesting much higher doses so in the end they will be taking much higher doses of the drug to compensate which will increase the risk because they will then not only have the higher amount required to get that same high but the drug will stay in their systems longer so they will continue to build up higher and higher blood levels of the medication which will again require even more of the drug to be snorted to get the effect as their tolerance will have increased as well, so in the end those abusing the drug will simply increase the dosage and it will be more dangerous. For someone like me that does not snort or otherwise abuse the drug it seems to me that this new formulation is not good at all, there are only a small portion of strong opioid medications that I an take that wont make me sleepy and unable to be functional in daily life, the old formulations was pretty transparent, I did not feel a high from the medication and unlike most other opioid drugs it seemed to give me more energy if anything instead of feeling drowsy like most all of the other medications have. So while it is more difficult for those who wish to abuse it those that use it legitimately are suffering for that. This is a big problem for me and unless a generic version comes out that is like the original version of oxycontin I am not sure what I will do. Oxycontin is already artificially hugely overpriced when compared to similar doses of immediate release oxycodone available in gerneric form. Those that wish to abuse drugs are going to find an alternative and I do not view this drug any different that other drugs that alter ones senses including alcohol. I do believe that it is more risky for recreational users to take an unregulated street opiate or opioid than to take a consistent pharmaceutical medication. I do not drink alcohol or abuse any drug but what is and is not legal is never the proper way to approach ones rights, alcohol is cheap and easy to obtain, causes more deaths than any other drug yet is legal and used by the full spectrum of society and no stigma is attached to it. The government makes huge amounts of money from the taxing of this drug of those who make decisions on what drugs are legal to use for recreation, then we spend huge amounts of money on police and courts to arrest and prosecute and jail those that abuse this legal drug openly advertised and available to everyone everywhere. IT MAKES NO SENSE. If I were to think one drug should be legal for recreational use it should be marijuana, though I dont use it myself it is the only drug that is impossible to overdose and die from, it does not cause the violent behavior of alcohol and other drugs and it is not so expensive it leads to secondary crimes to support the habit except for the actual use and sale being illegal. So I see this prescription drug reformulation as a small part of a much larger picture of what is or should be legal and what should not using very fuzzy logic. In the end the drug company is going to increase its monopoly from this new formulation, abusers will have to take more of it for the same effect of find an alternative opiate, perhaps even more destructive and the people that will loose out are the small percentage of us that truly need this medication and no longer have it available.

oc's September 9, 2010 9:20 pm (Pacific time)

The new formulation sucks and is the most un-called for idea ever. Deal with more important prolems in the world then how people choose to take Oxycontin.

maggie September 8, 2010 10:38 pm (Pacific time)

I have been taking this drug for many years for extreme chronic pain due to a handful of diseases i unfortunely have. I am so worried my pain relief is not going to be as controlled as usual when i recieve this new formula on my next refill.How can you do this to people that really looked up to you for making such a wonderful CHRONIC PAIN RELIEF drug.I am a very sensable person and use my meds as perscribed. This is NOT FEAR to us people that truely need this medication in its NORMAL WORKING WAY.This is a nightmare to me and im sure to a lot of other people just like myself.Why do we have to suffer because of this problem .let the world go round it is not going to prove anything abusers will always be abusers and go to the next or same and keep on unless they REALLY want REHAB.

thunderfoot September 8, 2010 11:05 am (Pacific time)

all this will do is push oxy addicts to other drugs such as methadone so as not to get sick. then what? we take that away from ppl who need it for severe pain or maintenance to get off heroin? ppl abused this drug because of its heroin-like high, guess whos gonna go right back to smack, thats right, those whos pain is no longer controlled by this new(and from what i hear practically worthless) "formulation". So as we see the use of heroin and abuse of methadone and other opiates skyrocket we can piont the finger straight at purdue and the fda, who are nothing but gov backed gangsters pushing thier products.i truly feel for those who needed this drug,cuz the new version is crap

bobby August 22, 2010 9:57 pm (Pacific time)

Now that the OxyContin will not be as easy for people to get "HIGH" off of, and wil be very expensive. This will have an inversre reaction sending OxyContin addicts straight to the cheaper, yet more dangerous Heroin, whos BRILLIANT IDEA!!!!!!!!!!!!!!!

secret August 18, 2010 2:22 pm (Pacific time)

u also neeed to realize that people who get high, are gonna get high with pain meds one way or another. now lets cause them to overdose by taking 5 or more by mouth to get high! idiots.

Kate July 25, 2010 11:53 pm (Pacific time)

The drug shouldn't be changed, the laws and regulations for obtaining the drug should be changed. A lot of states allow people with minimum amounts of pain to acquire the drug in high doses. Those individuals are selling the drug because they are getting high quantities of a drug that should only be prescribed to people who have severe pain. Even those individuals with severe pain are at risk to get addicted to this drug. The way opiates affect the user makes the user more prone to becoming addicted. There should be harsher punishments for the sale and distribution of controlled prescription medications. Hopefully then we can get people into treatment, detox, or even jail. This is a very serious drug that is highly addictive and kills people very easily. It also ruins lives and families. I see a lot of addicts in my line of work and a lot of kids are moving on to heroin from oxycodone experimentation because they get hooked easily and heroin gives them the same high but is cheaper most of the time. Something drastic needs to be done, but changing the medication is not the answer. If people feel like they are not getting high enough they are going to take more and we will see a higher number of deaths at a quicker rate that we are seeing now. This is a sensitive matter and needs to be handled very carefully so that things don't get worse. There is no quick fix. People need to be educated about the drug and addicts need treatment. I'm doing my part by educating my teenage clients. I hope others are stepping up as well.

Alex July 24, 2010 5:26 pm (Pacific time)

also did you notice that the patent will soon expire for oxycontin and become generic. The only way to insure a monopoly and prevent going generic, the patent for such a drug must somehow be extended. And how does one do that? They reformulate it and instantly the patent becomes extended. Pursue Pharma just wants some more money. Geniuses they are

Alex July 24, 2010 5:02 pm (Pacific time)

Ok this reformulation is pretty stupid. First off this article doesn't mention the part of the 'official' report that mentions this reformulation will not be intended to lower the abuse potential of the drug. Also lets say they did reformulate it to be 'abuse' free. Just like the comment above - oxycontin is only one synthetic opiate among thousands available, (hydrocodone, hyrdomorphone, oxymorphone, heroin, fentyl) all these drugs except for heroin are prescribed and available, so reformulating oxycontin won't exactly make a difference in anything. Like two comments above... the problem is not the drug, it's the attitude of the abuser.

House May 24, 2010 11:07 am (Pacific time)

This is a joke, alcohol has caused more deaths and destroyed more families than Oxycontin ever will and nobody does anything to remove alcohol off the market. this lady does not know what she is talking about.

Editor: So how are things over at Purdue today? This lady has more knowledge in the tip of her little finger... Drugs are something to avoid and we aren't exactly rooting for alcohol use.

House May 24, 2010 11:00 am (Pacific time)

There is no problem at all with Oxycontin, the problem is with the people who abuse it. I have used it correctly as prescribed for 6 years and have no problems with it. If people want to abuse this medication in the wrong way by snorting, shooting or chewing and they overdose, sorry but that is there fault and why should we suffer.

Editor: We do not think that people who are sick should be denied drugs. If you read this writer's background you just might feel bad. Her daughter passed away due to a respiratory failure connected to Oxycontin use. I am being reserved too, because six years on a single drug can be viewed many different ways. The biggest problem is that this is a deadly drug if used incorrectly, and Purdue was convicted in court of misleading the public about its fatal nature and the fact that people become so damned addicted to it. I have seen this stuff absolutely ruin people, I also have friends who are prescribed this drug and use it properly, to offset pain. Responsibility is paramount. And we care about you, don't take this out of context, it is no attack on you or other lawful users.

Beth Marcy May 17, 2010 10:49 pm (Pacific time)

My guess is that although this is a safer version of the drug, it has still created far too many addicts to control. They will just move on to other dangerous substances such as heroin or Vicodin.

http://www.oxycontintreatmenthelp.com/oxycontin-abuse

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