FDA Says Purdue Frederick Misrepresented OxyContin Illegally
May 10, 2007
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.
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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.
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13 Responses to “FDA Says Purdue Frederick Misrepresented OxyContin Illegally”
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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
[...] over 50 years old. The number of people in true need of the deadly, addictive and dangerous opioids like oxycontin is highly exaggerated by the pain management mavens and their minion who don’t want to admit that [...]
[...] dangerous drugs. Oxycodone (also known by another brand name not involved in this recall: Oxycontin) is a very powerful pain killer and the subject of heated debates over deaths related to its [...]
[...] pain, the morphinan molecule has come back with a vengeance in the form of oxycodone (Percocet and Oxycontin) and hydrocodone (Vicodin and Lorcet). Oxycodone and hydrocodone have replaced the legally [...]
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!
[...] With the recent dramatic increase in raw opium being imported into our country to make oxycodone (OxyContin), hydrocodone (Vicodin), and all the legal opium derivatives, the statistics available from a [...]
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
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
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
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…..
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.
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.
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