FDA Says Purdue Frederick Misrepresented OxyContin Illegally

The US Food and Drug Administration (FDA) announced results today of the investigation into the illegal promotion of OxyContin by The Purdue Frederick Company, makers of the widely abused, highly addictive pain pill.

“An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes,” according to an FDA statement.

FDA today informed healthcare professionals of criminal charges and civil liabilities brought against Purdue Frederick in connection with several illegal schemes to promote, market and sell OxyContin, the company’s powerful prescription pain reliever that has caused addiction problems of epidemic-promotions in cities and rural areas across the United States.

FDA claims the Purdue Frederick sales force was actually trained to make false claims about the product to healthcare professionals, thereby misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to raise tolerance levels and cause withdrawal symptoms than other pain medications. These practices falsely promote the product and may have caused health risks for consumers.

From the FDA Press Release Today:

An investigation by OCI uncovered an extensive, long-term conspiracy by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin through various illegal schemes. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing “fewer peaks and valleys than with immediate-release oxycodone,” and by representing that “…delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug.”

“FDA will not tolerate practices that falsely promote drug products and place consumers at health risk,” said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. “We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars.”

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, and over $276 million in forfeiture. In a separate civil settlement, Purdue will pay $100.6 million to the United States.

In addition, Purdue’s current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin by illegally promoting the drug as being less addictive, less subject to abuse, and less likely to cause tolerance and withdrawal than other pain medications.

This case was prosecuted by the U. S. Attorney’s Office for the Western District of Virginia and investigated by FDA’s Office of Criminal Investigations; the Internal Revenue Service’s Criminal Investigations Division; the U.S. Department of Health and Human Services’ Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation.

There are 26 comments. Add yours.

  1. Michael

    I have had a chance to look at the remaining six of the eight open label phase 1 clinical trials of the reformulated oxycontin. Here is a summary:

    The clinical trials that were performed are available for all to see. Please go to clinicaltrials.gov and enter “reformulated oxycontin” in the search box.

    The clinical trials were all phase 1. They were all open label meaning that no blinding was done.

    All study subjects were healthy volunteers with no medical problems, and all were opiate naive. Pain relief was not assessed (The subjects did not have pain that needed to be relieved).

    In all studies the method was the same. Except when comparing manufacturing plants (studies 7 and 8), “test” referred to the new formula, and “reference” referred to the old formula.

    In each study the subjects were divided into two groups. In group A, subjects were given one tablet of the reference drug, and then a week later they were given one tablet of the test drug. In group B, the order was reversed: subjects were given one tablet of the test drug, and then a week later they were given one tablet of the reference drug.

    In tests 7 and 8, tablets made in the Wilson Plant were labeled “reference”, and tablets made int the Totowa plant were labeled “test”.

    Study 7 compared 80 mg tablets made in two plants, “Wilson” and “Totowa”.

    At high opioid levels (a single 80 mg dose contains the oxycodone content of sixteen percocet tablets) where all of the (opiate naive) subjects would be expected to experience adverse events, a statistically significant number of subjects receiving tablets made at the Wilson plant did not experience any adverse events, while all subjects receiving tablets made at the Totowa plant experienced adverse events, as would be expected. [editorial comment: Reviewing the other studies, subsequently, perhaps my original thoughts on what should be expected were premature, but I still question the methodology of dispensing such dangerously high dosages to opioid naive patients to whom they would never be prescribed.]

    Study 8 was similar to study 7, except that subjects were given 10 mg tablets instead of 80 mg tablets. In this study 50% more subjects experienced adverse effects with pills made in Totowa than in Wilson. Statistically speaking, this is huge.

    Taken together, the results of both studies would tend to indicate that the Wilson plant was not producing tablets that functioned as they would be expected to function when administered to opioid naive patients.

    The remainder of the studies compared old and new versions of 80, 40, and 10 mg tablets. It is unknown which plants manufactured the tablets used in any of these studies. In some studies the tablets were given to fasting subjects, and in in others, to fed subjects, In most of the studies, there were more adverse events with the new formula than with the old.

    Here are the adverse event numbers (I hope that this board does not mess with the columns)

    (study / dose / fed or fasting)

    1. 40 mg Fed: 88 / 35 / 22 (subjects/new / old )

    2. 40 mg Fast: 92 / 30 / 32 (subjects/new / old )

    3. 80 mg Fed: 79 / 53 / 43 (subjects/new / old )

    4. 10 mg Fast: 84 / 23 / 14 (subjects/new / old )

    5. 10 mg Fed: 85 / 41 / 29 (subjects/new / old )

    6. 80 mg Fast: 84 / 47 / 69 (subjects/new / old )

    In 4 of the 6 studies, subjects given the new formulation tablets had more adverse events than those given the old formulation. This included all studies where the subjects had been fed and the 10 mg fasting study. While this tends to show a trend, the studies are uncontrolled, and we don’t even know how the results may have been influenced by which plant the test tablets were manufactured in (see discussion of tests 7 and 8).

    As far as calling the FDA, I did so months ago, at the urging of my doctor, who told me that the majority of those patients he had been prescribing oxycontin to were were experiencing problems of one sort or another. He said that I was one of the lucky ones who haven’t been experiencing worse problems, but should call anyway.

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  2. Michael

    Here is information regarding the remaining trials:

    The clinical trials that were performed are available for all to see, much to the FDA’s chagrin. Please go to clinicaltrials.gov and enter “reformulated oxycontin” in the search box.

    If you can call them clinical trials, that is. They were all open label. No blinding was done, whatsoever. Only phase 1 trials were performed.

    All study subjects were healthy volunteers with no medical problems, and all were opiate naive. Pain relief was not assessed (The subjects did not have pain that needed to be relieved).

    In all studies the method was the same. Except when comparing manufacturing plants (studies 7 and 8), “test” referred to the new formula, and “reference” referred to the old formula.

    In each study the subjects were divided into two groups. In group A, subjects were given one tablet of the reference drug, and then a week later they were given one tablet of the test drug. In group B, the order was reversed: subjects were given one tablet of the test drug, and then a week later they were given one tablet of the reference drug.

    In tests 7 and 8, tablets made in the Wilson Plant were labeled “reference”, and tablets made int the Totowa plant were labeled “test”.

    Study 7 compared 80 mg tablets made in two plants, “Wilson” and “Totowa”.

    At high opioid levels (a single 80 mg dose contains the oxycodone content of sixteen percocet tablets) where all of the (opiate naive) subjects would be expected to experience adverse events, a statistically significant number of subjects receiving tablets made at the Wilson plant did not experience any adverse events, while all subjects receiving tablets made at the Totowa plant experienced adverse events, as would be expected.

    Study 8 was similar to study 7, except that subjects were given 10 mg tablets instead of 80 mg tablets. In this study 50% more subjects experienced adverse effects with pills made in Totowa than in Wilson. Statistically speaking, this is huge.

    Taken together, the results of both studies would tend to indicate that the Wilson plant was not producing tablets that functioned as they would be expected to function when administered to opioid naive patients.

    The remainder of the studies compared old and new versions of 80, 40, and 10 mg tablets. It is unknown which plants manufactured the tablets used in any of these studies. In some studies the tablets were given to fasting subjects, and in in others, to fed subjects, In most of the studies, there were more adverse events with the new formula than with the old.

    Here are the adverse event numbers (I hope that this board does not mess with the columns)

    (study / dose / fed or fasting)

    1. 40 mg Fed: 88 / 35 / 22 (subjects/new / old )

    2. 40 mg Fast: 92 / 30 / 32 (subjects/new / old )

    3. 80 mg Fed: 79 / 53 / 43 (subjects/new / old )

    4. 10 mg Fast: 84 / 23 / 14 (subjects/new / old )

    5. 10 mg Fed: 85 / 41 / 29 (subjects/new / old )

    6. 80 mg Fast: 84 / 47 / 69 (subjects/new / old )

    In 4 of the 6 studies, subjects given the new formulation tablets had more adverse events than those given the old formulation. This included all studies where the subjects had been fed and the 10 mg fasting study. While this tends to show a trend, the studies are uncontrolled, and we don’t even know how the results may have been influenced by which plant the test tablets were manufactured in (see discussion of tests 7 and 8).

    As far as calling the FDA, I did so months ago, at the urging of my doctor, who told me that the majority of those patients he had been prescribing oxycontin to were were experiencing problems of one sort or another. He said that I was one of the lucky ones who haven’t been experiencing worse problems, but should call anyway.

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  3. Michael

    The vote of the FDA panel was: 14 Yes, 1 abstention, and four No, including the panel chairman.

    The meeting began at 9:15AM, and ran until 4:13PM. While I don’t suggest reading the entire 300 page transcript of the meeting, I do strongly recommend reading the last 6.5 pages where the voters explained the reasons for their votes.

    The pdf can be found at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM187082.pdf

    Comparing the voters’ explanations with an examination of the Purdue sponsored clinical trials seem to indicate that they were not as rigorously vetted by the FDA panel as they should have been. If they had, I believe the vote would have gone differently.

    One issue is that trial protocols were designed for study participants to use Oxycontin as a PRN medicine would be taken rather than on the regular basis that is the intended use of the drug by patients, despite the fact that the manufacturer itself warns that the drug is not intended for use on a PRN basis. (many customer complaints seem related to build up of plasma levels during repetitive dosage, and/or effects of continual delivery of a drug delivery mechanism itself (PolyOx) that was not part of the original formula and not evaluated with the new formula for adverse effects that may appear only when the drug is taken as intended — and it is of concern that some of the complaints may be excipient related)

    There were eight trials run. There are problems with all, but I’m just discussing two that, in addition to protocol issues, had results that demonstrated significant bio-compatibility differences between reformulated tablets manufactured at two different plants.
    Please carefully examine the reformulated Oxycontin trial results at clinicalaltrials.gov, particularly:
    http://clinicaltrials.gov/ct2/show/NCT01101321?term=reformulated+oxycontin&rank=7
    and
    http://clinicaltrials.gov/ct2/show/NCT01101308?term=reformulated+oxycontin&rank=8

    If the URL’s get messed up, go to “clinicaltrials.gov”, search for “reformulated oxycontin”, and choose the 7th and 8th documents.

    The basis of these studies is questionable, as the drug is specifically not intended to be taken on a PRN basis, yet the study patients were given no more than one tablet each per week.

    While the basis is questionable, how the results made it past FDA scrutiny is probably a matter for the courts.

    These were 2 studies (one for 10 mg pills, and one for 80 mg pills) performed to determine whether pills manufactured at 2 different plants were bioequivalent to *each other*.

    The drug used for one study was reformulated Oxycontin 10 mg. Over a twelve hour period this is roughly equivalent to the amount of Oxycodone in one percocet tablet, plus the amount of oxycodone in a second percocet tablet taken 6 hours later, for a total amount of oxycodone equivalent to that found in two percocet tablets.

    For the other study, it was reformulated Oxycontin 80 mg. Over a twelve hour period this is iroughly equivalent to the oxycodone in eight (8) percocet tablets, plus the amount of oxycodone in an additional eight (8) percocet tablets taken 6 hours later, for a total amount of oxycodone equivalent to that found in sixteen percocet tablets.

    In one study, there were 22 females and 36 males among which the number of participants affected by adverse events from taking 80 mg pills made in Totowa was 58 and the number of participants affected by adverse events from taking 80 mg pills made in Wilson (North Carolina) was 48.

    I think it would be highly unlikely for an opioid naive patient who was actually administered an 80 mg tablet to not experience any adverse effects whatsoever. Remember, this is the equivalent of sixteen percocet tablets!

    For 10 patients taking 80 mg tablets made in one plant to experience no adverse events whatsoever, either (A) most or all of these 10 misrepresented themselves as being opioid naive when they were not, or (B) the tablets did not truly contain 80 mg, or (C) something was interfering with the absorption of API from tablets made at that plant. Unless the patients had been untruthful, it is likely that there was some kind of problem in the manufacturing process at that plant.

    Either the study was tainted, or the study caught a manufacturing defect to which no attention had been paid. In either case, an investigation should have been initiated.

    In the 10mg tablet study, there were 26 females and 29 males among which the number of participants affected by adverse events from taking 10 mg pills made in Totowa was 25 while the number of participants affected by adverse events from taking 10 mg pills made in Wilson (NC) was 17.

    The 10mg study is as interesting as the 80 mg study in that it is both the case in the 10 mg study that a sizable portion of participants did not have adverse events, and the case that the number of patients reporting adverse events for pills made in Totowa was 50% higher than for pills made in Wilson.

    Given that two studies were performed at dosage extremes, some comparative analysis can be done.

    At high opioid levels (a single 80 mg dose containing the oxycodone content of sixteen percocets) where all patients were likely to experience adverse events, a statistically significant number of patients receiving tablets made at the Wilson plant did not experience any adverse events.

    Second, at the relatively low level of 10 mg for a 12 hour dose, 50% more patients experienced adverse effects with pills made in Totowa than in Wilson. Statistically speaking, this is huge. Taken together, the results of both studies would tend to indicate that the Wilson plant is not producing tablets that function as they are specified to function.

    This may account for conflicting reports from the field, where some patients achieve adequate pain control, while many do not and some patients experience adverse events that imply withdrawal.

    I think that some people are receiving tablets made in the Wilson plant, and these are the people for whom the new formula does not provide pain relief, while others are receiving tablets made in the Totowa plant, and so are getting pain relief.

    A separate issue that I’ve only glossed over is that while the drugs are intended for continuous, non-stop use, the only testing done used methodology more appropriate to PRN pain medication. No provision was made for evaluating the possibility of the drug failing to be biocompatible with the original formula in long-term usage.

    At best, patients receiving the newly formulated drugs are effectively part of a hugely multi-central clinical trial of the drug’s effectiveness and safety when used as intended. Or in other words, Oxycontin patients are serving as uncompensated Human Guinea Pigs.

    ——————

    Not having to do with the results of those two studies, a consideration I have not read discussed anywhere else, (that may be a non sequitur, but then again, may not) is of whether the new formulation might affect the absorption of other drugs differently than the old formula did. The new formula uses polyethylene oxide, which provides for limitation of drug absorption in several ways including diffusion through the gel. The gel itself reportedly has a high affinity for mucous tissue, such as the mucosa of the small and large intestines where foods, drugs, and water are absorbed. If the particular gel matrix used were to move through the intestinal tract by sliding across the intestinal mucosa, how might it delay or prevent absorption of other drugs at their intended absorption points within the intestinal tract?

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  4. Lou Lowery

    I am a 78 year old woman, I have fibromyalgia, have had 4 back surgeries, brain surgery, hip replacements,knee replacements and I have been on oxycontin for 10 years and it worked well for me until you have come out with the new formulation on this drug.. Now, my pain is somewhat relieved but I don’t stop hurting very long.. Is tthis what all oxycontins are going to be like or will you still be able to get the ones with OC on them?

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  5. Sonya Gaynor

    The link you have listed on this web page for legal help is not correct. I would like to have it? As you probally know by now the oxycontin has changed? I’m getting SEVERE headaches, stomache burn, and the medication is less effective. I have been on this medication for about 7 years. From what I’ve heard because drug addicts are getting ahold of this medication and abusing it Purdue has changed how it is made. Now I have to suffer some more problems because of what drug addicts do? I was having no problems with my medication. Now I’am. I agree this medication has been very misrepresented in many ways. What can I do to help? Or what can I do to be helped? Nothing is fair or just with what is going on with this medicine.Please get back to me with any and all information you have that can help me, Please? Sincerely Sonya Gaynor

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  6. Kimon Juarez

    Oxy is the Devil’s drug. It will get you out of pain and in complete bliss but little do you know, you’re becoming addicted from the first tablet you swallow. You will need to increase your dose until it doesn’t work anymore, then you will find yourself crushing the tablet, which will break the time release on it. One day you will snort a little too much and you will be dead. You will break the hearts of all who loved you. Or if that doesn’t happen, your children or grandchildren will start to steal your oxy take them to school and start getting high with their friends. Many will O.D. It will break the hearts of all your loved one’s or the child’s loved one’s. They will be in a state of shock wanting to be dead with you.

    DO NOT DO THIS DRUG UNDER ANY CIRCUMSTANCES….NONE. THIS DRUG KILLS PEOPLE EVERYDAY AND IS TOXIC. IT’S A DISEASE A CONTAGIOUS ONE IF YOU DO OXYCONTIN YOU ARE ONE BREATH AWAY FROM DEATH.

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  7. Dave Baraskewich

    Can you put a price on a person’s life? I for one don’t think so,but Purdue Pharma has; $1 a milligram, pretty cheap I would say. Just think,a 20 mil. pill sells for $20 dollars on the street and it only takes one to kill someone. To this company that has made billions of dollars; do you really think they care?, I don’t think so. To them it’s all about the dollars and cents: if we don’t make no dollars, it don’t make no sense. Let’s keep making these people richer buy letting them continue to make this narcotic,and it is a narcotic when you look at the chemical makeup. A legal heroin,hmm, wonder how that got”buy” the FDA. No that’s not a spelling mistake,someone must have got their palms greased on this deal. The FDA knew about the chemical makeup of this pill, and they knew the same ingredients were found in heroin which is a banned narcotic but yet they still haven’t stopped this company from producing this pill. How many people have gone to prison for selling heroin and yet these guys are walking the street. I guess money can buy you anything. I never knew there two different justice systems in the US, one for the rich and one for the poor, I thought it was equal?, guess I was wrong. Anyway, keep getting richer Purdue and just remember that one day someone will be suing you on the civil side of the law,not just for them but for all the other lives you have ruined.

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  8. zonabrian

    MY WIFE HAS BEEN ON EVERY PAIN MED MADE, SHE HAS HAD THREE TOTAL KNEE REPLACEMENTS AND TEN SCOOPS DONE TO HER RIGHT KNEE. SHE HAS ALSO HAD NERVE DAMAGE ON THE KNEE, SHE HAS BEEN IN FOR NERVE BLOCKS IN HER BACK FOR THE PAIN, AND THAT ALSO HAS NOT WORKED. OXYCONTIN WAS THE ONLY MED THAT HAS KEPT HER IN THE GAME OF LIFE. THE PAIN IS SO GREAT AT TIMES SHE FEELS THAT SHE WOULD BE BETTER OF FOR EVERYONE IF SHE WAS NOT HERE. AND I WOULD NOT KNOW WHAT TO DO WITH OUT MY SOUL MATE. SO LETS KEEP THE PAIN MED AROUND FOR THE PEOPLE WHO REALLY NEED IT.

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  9. Annie Ilene

    What is it you people (pain patients) don’t get? OxyContin is a deadly drug. It comes from a medical community, which does not know how (or when) to prescribe it. It comes from a pharmaceutical company that was convicted of fraudulent practices. It comes from a regulatory agency (FDA) that has allowed thousands of deaths associated with this drug product every year since 1996 and done nothing about it. It has killed many “recreational” drug users, but it has killed many “legitimate” pain patients also. It’s killing children.

    A coroner once said after reviewing a years worth of overdose deaths, which had increased by 200%; “it doesn’t take a rocket scientist to recognize the one common element in all these deaths is OxyContin”.

    Why do pain patients think that they cannot live without OxyContin? One reason; they have been brainwashed into believing this from the people, who are making money on them. The pain doctors and the pain pill companies. I can guarantee that no matter what pain the patient has ever been in, if they are taking OxyContin, they have the added pain of addiction. And the fear of dealing with that is overwhelming to all, but the ones who have fatal diseases. That fear is real. Anyone who has been put on OxyContin knows the absolute terror of not supplying their bodies with it’s daily doses. The body’s reaction of not “getting” the OxyContin is a nightmare much more horrific than any chronic pain.

    15 years has tragically passed without the needed medical study of safely treating pain. What we got was a “quick fix” in the form of a pill, thousands of deaths and addictions, junk science, irrational fear of “undertreatment” of pain, brainwashed patients, untrained and ill-prepared pain practitioners, a new front on the “drug wars”, elderly in the detox clinics, and sadly, regulatory failure when we most needed it.

    Since OxyContin is pharmacologically structured the same way as heroin, why don’t we just give these chronic pain patients it? Would pain patients take heroin? Too inconvenient? Doesn’t last 12 hours? Neither does OxyContin. EVERY patient knows that.

    Lastly; supposedly “undertreatment” started this epidemic. Anybody want to supply the evidence-based science that supported that move? More importantly, isn’t “overtreatment” just as bad? It has certainly caused more destruction than “undertreatment” has. Trust me. As a former opiate/OxyContin prescribed chronic pain patient, who is finally free of this fiasco, I know

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  10. Jon

    All I have to say is that it is really hard to take some of these articles and comments seriously. People come on, your points suffer severely when you’re using the grammar and sentence structures of a 5th grader. Sorry… I am not trying to be mean, but some of it is hard to understand.

    It was quite informative though, I never knew that the only “real” difference between Oxycontin and percocets/vicodyn etc… was the absence of Acetaminophen. The real problem with any pharmaceutical drug is that we have to rely on the morality of the people who get legitmately prescribed these hardcore medications. It is impossible to stop these people from buying it on the streets, especially since people who should not have been prescribed Oxy’s in the first place are the ones getting hopelessly addicted and overdosing, or selling it. People break the time release and snort it. They quickly develop a strong tolerance to it, than die because the only way to get high from there is snorting it and there is only so much your body can take..

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  11. steven

    i think justs because michael jackson oded they wanna bann it stupid choices …it wasnt oxycontin it was diprivan that killed him probally along with demerol …he was an addict ..he made a song before he died about morphine and demerol …i feel sad he died though god rests his soul omgosh you know but please dont get rid of vicodin and percocets ..jeeze its our gov dea and stuff all of the sudden …justs like obama said back off dea no more marijuana raids ..well they broke that law they raided a marijuana cliniq ..from steve in cali im on xanax for 15 yrs for agoraphobia panic attacks ..

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  12. jason

    Hi,
    People make me laugh! All of the do gooders in the world want to save you and I from the horors of life, well you can’t. Banning a drug or anything else for that matter never works, Prohibition for example. People are gonna do what they are gonna do no matter what the consiquences. The reason that our prisons are over crowded is due to all the addicts they keep locking up and the people who commit petty crimes to maintain there addictions. But if you havent noticed its not working. Decriminalization or leagalization of all substances is the only way to go. Yes there will be some overdoses and bad addictions in the beginning, but it will taper off and you will find in the long term we as a society will be much less addicted. The people who sit on there high moral horses need to dismount and stop getting into other peoples lives. If the founding fathers were alive today they would be dissapointed in all of the laws passed that curb our freedoms and personal choices. When did it become ok for the state to tell you what you can and can’t have and do in your own home? Oh well its a shame thats all…….

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  13. steven

    i think oxycontin shouldnt be taking off the market ….cancer patients need it …plus people with bad backs need it …for all these people claiming of there children dieing its because of a mixure of both alcohol plus other drugs ..so i guess we should ban somas too right …thats an example ..lol its mixed with other drugs plain and simple …its the ones who get high who say too much …actually its alcohol and pills that kills its not about oxycodone …people need it …for medical reasons ..its a hippa act .. plus discrimination ..i justs feel there taking our rights away from us …it takes a pharmacists to report all of this stuff to try to make a point ..it doesnt make sense …from steven

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  14. Ben

    This is another example of the profound stupidity of the way the war on drugs is being waged. And what’s being glossed over is an open secret the FDA doesn’t want to talk about, more on that after I give a little backround (and no, I’m not a conspiracy nut and this isn’t some rant about big pharma or the evil government). I am a young man, only 30, and a few years back I suffered a horrible sports injury. After two years of watching my life deteriorate because I couldn’t function and because I was slowly turning into an alcoholic in an effort to self-medicate I finally went to a pain specialist, my life changed overnight. I stopped drinking, not because I hit bottom or went to AA or anything like that, it just didn’t occur to me to have a drink. I didn’t even noticed I’d stopped until the guy at the liquor store asked me where I’d been when I bumped into him on the street and I realized the two bottles of scotch I’d bought a couple days before I first went to the pain doctor had been sitting in my kitchen almost untouched for two months, normally it’d be a miracle if they lasted a week.. I noticed that I was no longer angry all the time, I’m a teacher at a community college (yes, people on pain medicine have normal jobs and even teach your kids!). Some of my regular students noticed that my view of things seemed to really brighten. Being in pain all the time is really hard on the spirit, I’m not a religious person but that’s just seems to be the word for it, as well as the body. I should say from the outset that fortunately I do not need Oxycontin or want, but I am an academic and I feel compassion for those who do so I am sharing my research in the hope of changing some minds.

    I had heard horror stories about narcotic pain-relievers when I was in college so when I went to the doctor I made a point of being very well informed, I didn’t even limit my reading to Wikipedia! :) We developed a drug regime where I switch back and forth from Norco, hydrocodone, to Percocet, oxycodone, when I start developing a tolerance for the one I’m on. I’m young, so that ends up being about every six months. When I asked my if I should be worried about the long-term effects of taking at least 650 milligrams of acetaminophen every day for the rest of my life he got visibly anxious and it was some time before he trusted me again. I didn’t like being treated like a criminal because I suffer from chronic pain so I so started really doing some serious research to understand what was going on.

    Here’s where we get to the dirty little open secret. I quickly realized my doctor thought I was trying to get him to prescribe me Oxyxontin, which I’m sure he is loathe to do even as a pain specialist and even though I resisted taking any medication until we had exhausted everything else for fear of getting into trouble with the FDA. So, here’s the $64 dollar question, What is so evil about Oxycontin? It’s got the same active ingredient as the Percocet that my doctor has no qualms about giving me. And he prescribes the largest available dose, 10 milligrams, and gives me 60 a month, so if I wanted to I could certainly get high or sell them, The answer is that Percocet is “safe” because it has acetaminophen. It is “safe” because if I abuse it it will slowly destroy my liver and kill me, unlike Oxycontin which taken properly has no known negative long or short physiological effects. Of course, my doctor didn’t tell me that, and it isn’t on the warning label, and the pharmacist who gives me a dirty look every time I go to fill my prescription never told me that. I had to find that out on my own.

    It turns out the reason to FDA doesn’t go after doctors who prescribe Percocet is because hard-core drug addicts know not to abuse it because of the acetaminophen. And that’s supposed to make it safer than Oxycontin which is the same thing with no acetaminophen. Here’s the dirty little open secret, if what you care about is saving people’s lives, especially kid’s lives (mostly teenagers raiding their parents medicine cabinets),more than protecting them from getting high Percocet and even Vicoden and way way more dangerous than Oxtycontin.

    While statistics are hard to pin down because of the way prescription drug overdoses are recorded, the LEAST CONSERVATIVE estimate I could find for Oxycontin related overdoses (not death) for 2001 was around 10,000. On the other hand, the MOST CONSERVATIVE number I could find for acetaminophen overdoes for the same year was 56,000. Moreover, the NIH describes the prognosis for Oxycontin overdose as follows, “If you receive medical attention before serious problems with your breathing occur, you should have few long-term consequences, and will probably be back to normal in a day.” On the other hand, the NIH says of acetaminophen, “without rapid treatment, a very large overdose of acetaminophen can lead to liver failure and death in a few days.” Indeed, in one recent study fully 40% of people admitted to hospital for acetaminophen overdose suffered acute liver failure, something they will have to live with forever, if they live. Many don’t.

    Now here’s the really disgusting part. Who is it do you suppose that actually knows about how dangerous it is to take a bunch of Percocets, hard-core drug addicts or teenagers stealing grandma’s medication? I’ll give you a hint, drug addicts know a lot about drugs and teenagers are stupid. That’s right folks, the FDA is so worried about people getting high off of their pain medicine that they actually willingly put experimental, young, uneducated, occasional drug abusers at risk of DEATH, and a whole lot of them, in order to discourage junkies who know the dangers and know what they are doing from getting high (discourage, not prevent mind you because savvy drug-addicts can extract the pure oxycodone, which is exactly what Oxyxontin is, safely and easily in about five minutes using stuff they have in the kitchen. In fact, instructions for doing so are so hard to come by that I learned about it by doing a Google search just now to find out if there was such a process. Whole discussion boards came up on my first try. The process does require volatile chemicals like water, and complex technology like a refrigerator!).

    So to recap:
    1) For every Oxycontin OD there are about six acetaminophen ODs
    2) Acetaminophen ODs are much much more dangerous and horrible
    3)The people who know the risks associated with acetaminophen in Percocet and similar drugs are hard-core drug addicts and particularly well informed legitimate pain sufferers
    4)Neither of the above groups are served by the inclusion of acetaminophen in Percocet because the latter is not interested in getting high and the former can easily extract the acetaminaphen in order to get high safely.
    5) So, the groups that are left are ill-informed and irresponsible pain patients and young people who experiment with stolen prescription medication.
    6) While killing or permanently crippling large groups of people listed in group point five above will almost certainly reduce the number of people who become addicted to Oxyxntin later on, i.e. by killing potential users early with Percocet, from a public health standpoint it seems to patently absurd to put huge groups of, especially young, people at extremely extremely high risk to protect a relatively very small group of people from getting really high.
    7) For all they hype, properly administered and supervised Oxycontin is physiologically extremely safe. There is an increased danger of addiction only because it can be taken in higher doses due to the absence of acetaminophen. The way to deal with this is for doctors and patients to work hard in full awareness of the associated risks, not to take an extremely valuable medication off the market.

    8) IT IS MORE IMPORTANT ALLEVIATE THE PAIN OF PEOPLE WHO ARE SUFFERING TERRIBLY AND TO PROTECT PEOPLE FROM BEING CRIPPLED OR DYING OF ACETAMINAPHEN OVERDOSE THAN IT IS TO PROTECT PEOPLE FROM GETTING HIGH ON OXYCODONE!!!!!!!!!!!!

    Reply
  15. Thomas A. Coyle, Esq.

    I used to find the comments of people with minor aches and pains amusing. They cannot appreciate the pain described by Renee, Joanne, and Stephanie because they have not experienced that same degree of pain. Their patronizing advice to “push through the pain” or “start an exercise program” is no longer amusing to me. People with crippling diseases who are in constant pain deserve to get the relief they need and deserve. I am not a religious man, but I pray that all of you well-intentioned but misinformed persons never have to suffer the pain of severe rheumatoid arthritis. I hope you never have to watch your limbs become bent into impossible, painful, permanent positions or cry with despair because the pain is so unbearable. I watched as my wife changed from an active woman who bicycled ten or more miles per day to a woman who can barely get out of bed because of the severity of the pain. She suffers even with the Oxycontin and now that is being denied. Please know that it is difficult for us to not become angry at your ignorance. Again, I pray that you will never know this pain.

    Reply
  16. Stephanie

    My mother is dying of cancer and she is only 45 if it werent for percocets she would never enjoy her grandchildren even if she is addicted only for a short time you think the rest of your life means forever but for her it will only be a few short years that she can now live with a little less pain. i think we should be investigating these doctors for perscribing them to every tom dick and harry and mabye take another look at mental health systems because thats were drug abuse starts with bad beginnings…..

    Reply
  17. Barb

    I Am 60yrs. old and Thanked God the day I was put on oxycontin.I had my 2nd open heart surgery and from that had something go wrong that sent my nervous system out of control.After years of every type of doctor possible,every type of pain releiver years of not being able to move because the nerve pain from movement was unbearable I was sent to the pain clinic and put on oxycontin,it was a gift sent from God.For people to judge me because I have to take this is wrong.I can function do things I never was able to do before and because their are MANY PEOPLE out their taking it just for the enjoyment,selling to make money has put people like me at risk because of their actions.I don’t get a high feeling from it,I’ve been on it for years I get RELIEF,and can function and have a been able to live productive days. My doctor monitors me all the time. I am very upset with the people who have Abused ,overdosed(alot of them teens looking for a high), has caused ME to have to pay a price for their bad choices. Now on top of my nervous system and many other health problems I have to fear that the one thing that gives me relief may be taken away just isn’t fair to not only me but many other who like myself don’t abuse.overuse but use it as prescribed.We are not the ones you read about inthe paper and on the news it;s the abusers who give it a bad name and make honest people who truly need it pay the price for what they’ve done. I’m tired of the honest people always having to pay the price for the destrictive actions of others. It has been 16yrs of hell for me and the time I have left I don’t want to go back to the unbearable years of pain.I can never have another heart surgery again,even if needed,because of the complications from the 2nd.And I also was diagnosed with M.S. A year ago with 16 lesions on my brain. As long as people are being monitored and have a better quality of life don’t punish them for the ABUSERS and scammers out their.Someone write a story about the people who truly need this and how the TRUE ABUSERS are hurting and giving this medication all the attention and bad media.I’m sick of reading about the bad people destroying what has given me my life back .These people suck and I want them not me to pay the price for what they’ve done just to get a high. As for Alexander replying to Renee,Oxycontin is time released and the other you asked about are for short time use. That’s the Magical way it works.take every 12 hrs. And to all who think because I take such a drug I’m an addict is very wrong.Again it’s the true ADDICT that labels me from society as one.The pain was so unbearable it was hard to make it day to day.Thank God for helping to make this so that my suffering isn’t unbearable. Thank You

    Reply
  18. JoaNN McKeon

    I am a 65 year old lady who had a stoke 14y.ago. I had the pain receptors in my brain turned on and have had 5 back surgerys, disc replaced, 2 heart attacks, lose of my teeth thru the use of steroids for inflamation. i have taken every known pain reliever and found oxycotin as a last resort. I take far less than my doctor would feel i need because this is all i have that helps enough to let me get out of b ed and function. yes, i have days that thats not a option , but if i took more medicine i probably would be having less non productive days, im not willing to do that becasue i only have this medicine till i die. so i suffer a little more than i could prevent but i do not misuse this medcicine my doctor does not mis prescribe this medicine. its a crime that the people who are not mis using this drfug are the ones that are going to die and wish they were dead from the pain and withdraw because of the ones who do. its a sin, that the drug companies actually knew what the drug would do and taught people to go out and lie to doctors and people about it. you charge them some money that is probably what is in there petty cash drawer. i have a body filled with a enormous amount of faith and i know God will take care of me but I know that He is not happy with the lying people that are hurting innocent people. Thank You

    Reply
  19. alex

    to Renee, darling I’m sorry you suffer from chronic pain (as I do myself, and I also believe that oxycontin works better then a lot of other drugs) but percocet and percodan both have the same active ingredient as oxycontin, and actually works faster, so I don’t understand why it would magically work so much better?

    Hope you feel better love.
    alexander

    Reply
  20. Drug Rehabs

    Prescription drug abuse is rampant with pain killing medications like Oxycontin and Vicodin primarily being responsible for a surge in opiate addictions. Most states have realized the problem with these medications and have implemented opioid regulations and increased scrutiny of pain management prescriptions. These actions have made a definite impact on the supply of diverted medicine on the market yet the number of addicts who end up in a Drug Rehab continues to grow. Guess why!

    Reply
  21. RENEE HERNANDEZ

    I AM A 55 YEAR OLD WOMAN THAT HAS BEEN LIVING IN PAIN FOR OVER 30 YEARS. I HAVE HAD PHYSICAL THERAPY, SEEN JUST ABOUT EVERY SPECIALIST THERE IS IN THE MEDICAL PROFESSION, AND BEEN PRESCRIBED JUST ABOUT EVERY DRUG THERE WAS IN THOSE 30 YEARS. NONE OF THEM WORKED FOR ME. I WAS GIVEN PERCOCET, PERCODAN, DEMEROL,TALWIN, DILAUDID, AND
    DARVON JUST TO NAME A FEW. NONE OF THEM HELPED WITH MY PAIN. NOW ALONG WITH MY CHRONIC PAIN I HAVE FIBROMYALGIA , ARTHRITIS, A HERNIAT-
    ED DISC. I DO NEED TO SAY THAT IF THESE DRUGS THAT I WAS PRESCRIBED DID NOT WORK AFTER A MONTH OF USE I DISCONTINUED THEM. I NEVER ABUSED ANY OF THEM. THEN I WAS GIVEN OXYCONTIN. TO ME IT WAS A MIRACLE DRUG. I WAS ABLE TO FUNCTION NORMALLY AGAIN. MY DEPRESSION WAS GONE AND I WAS ABLE TO BE MUCH MORE ACTIVE. NOT ONLY THAT I WAS ABLE TO PLAY WITH MY GRANDCHILDREN WHICH MADE THEM ECSTATIC. ANOTHER THING I NOTICED WAS THAT MY HIGH BLOOD PRESSURE WAS NO LONGER HIGH. BUT NOW THE DOCTOR’S THAT WERE PRESCRIBING THIS MEDICATION ARE TERRIFIED OF CONTINUING TO DO IT BECAUSE THEY SAY THAT THEY ARE BEING THREATENED WITH LOSING THEIR LICENSE. HOW CAN THIS HAPPEN? PLEASE EXPLAIN TO ME HOW A DOCTOR THAT HAS BEEN TREATING A PATIENT FOR OVER 20 YEARS AND KNOWS THE PATIENT WELL ENOUGH TO KNOW THAT SHE IS NOT A DRUG ABUSER CAN BE SO AFRAID TO TREAT HER WITH THE MEDICATION THAT IS FINALLY ABLE TO TAKE THE PAIN AWAY THAT SHE HAS HAD ALL OF THOSE YEARS.MY PHYSICIAN WANTS TO PRESCRIBE THE MEDICATION TO ME BUT IS AFRAID AND THEREFORE SHE SENDS ME TO A PAIN CLINIC WHICH IS ALSO AFRAID OF LOSING THEIR LICENSE. DON’T YOU THINK THAT AFTER 30 YEARS OF MY PAIN GETTING WORSE AND THE ADDITIONAL DISEASES THAT HAVE COME ALONG OVER THE YEARS I DESERVE SOME RE-
    LIEF? AS LONG AS I DON’T ABUSE MY MEDICATIONS SHOULDN’T I BE ALLOW-
    TO LIVE PAIN FREE. I AM ONLY 55 YEARS OLD AND I WOULD LOVE TO ENJOY MY GRANDCHILDREN, NOT TO MENTION BEING ABLE TO DO THINGS WITH MY HUSBAND AGAIN. I COULD PROBABLY GO ON AND ON BUT I FEEL THAT IT IS JUST USELESS. THAT NOBODY REALLY CARES. THAT JUST BECAUSE WE HAVE FINALLY FOUND SOMETHING THAT TAKES THE PAIN AWAY AND WE FEEL THAT WE CAN FUNCTION NORMALLY AGAIN WE ARE LABELED DRUG ABUSERS. IT IS JUST NOT RIGHT. WHY CAN’T WE BE ALLOWED TO LIVE PAIN FREE?
    SINCERELY,
    RENEE

    Reply

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