Purdue And Execs: $634M For Misbranding
12 CommentsBy Ed Silverman // May 10th, 2007 // 11:30 am
The drugmaker and three former and current execs pleaded guilty in federal court in Virginia to criminal charges for misleading regulators, doctors and consumers about the addictive risks of Oxycontin. Purdue and its parent agreed to pay $634 million in fines, the third-highest amount ever paid by a drugmaker for this type of violation.
And in a message to executives everywhere, three Purdue execs, including its president and top lawyer, pleaded guilty today as individuals to misbranding charges, a criminal violation. They agreed to pay a total of $34.5 million in fines - $19 million paid by Michael Friedman; $8 million paid by Howard Udell, and $7.5 million paid by Paul Goldenheim. Each exec will also pay a $5,000 criminal fine. Public Citizen thinks everyone involved should have paid more, given that OxyContin sales were $9.6 billion between 2000 and 2006.
“Even in the face of warnings from health care professionals, the media, and members of its own sales force that OxyContin was being widely abused and causing harm to our citizens, Purdue, under the leadership of its top executives, continued to push a fraudulent marketing campaign that promoted Oxycontin as less addictive, less subject to abuse, and less likely to cause withdrawal, †says US Attorney John Brownlee.
“In the process, scores died as a result of OxyContin abuse and an even greater number of people became addicted to OxyContin; a drug that Purdue led many to believe was safer, less abusable, and less addictive than other pain medications on the market.
OxyContin is a powerful, long-acting narcotic that provides relief of serious pain for up to 12 hours. Initially, Purdue Pharma contended that OxyContin, because of its time-release formulation, posed a lower threat of abuse and addiction to patients than traditional, shorter-acting painkillers like Percocet or Vicodin.
That claim became the lynchpin of the most aggressive marketing campaign ever undertaken by a pharmaceutical company for such a drug, The New York Times reports from the courthouse. Shortly after the drug’s introduction in 1996, annual sales reached $1 billion. Purdue heavily promoted OxyContin to doc like general practitioners who had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients.
But both experienced drug abusers and novices, including teens, soon discovered that chewing an OxyContin tablet or crushing one and then snorting the powder or injecting it with a needle produced a high as powerful as heroin. By 2000, several parts of the US, particularly rural areas, began to seeing skyrocketing rates of addiction and crime related to the drug’s use.
The feds say internal Purdue documents show company officials recognized even before the drug was marketed that they would face stiff resistance from docs concerned about the potential of a high-powered narcotic like OxyContin to be abused by patients or cause addiction.
As a result, company officials developed a fraudulent marketing campaign designed to promote OxyContin as a time-released drug that was less prone to such problems. Purdue sales reps falsely told docs that the statement, rather than simply being a theory, meant OxyContin had a lower potential for addiction or abuse than drugs like Percocet. Among other things, company sales officials were allowed to draw their own fake scientific charts that they then distributed to doctors to support that misleading abuse-related claim.
Purdue supervisors and employees also drafted an article about a study of the use of OxyContin in osteoarthritis patients that was published in a medical journal in March 2000. Two months later, each sales rep was provided a copy along with a “marketing tip†that stated that the article was available for use in achieving sales success. Sales reps distributed copies to docs to claim certain doses can be discontinued abruptly without withdrawal symptoms, despite being aware of contrary info.
Source: The New York Times (registration required).
Purdue statement;
Terms of agreement;
[tags]Misbranding, Oxycontin, Purdue Pharma[/tags]
swissinsider
Misbranding, falseclaims, fake trials (patients buy thier drugs and tens of thousands are enroled in trials and the doctors get paid too), expanded indications, invented indications, and the list of misconduct (catch word for illegal, unethical and criminal activity) goes on and on and on….
Everyday a new big pharma co. is caught or exposed. Is it going to end? Not “bloody likely” for they all do it and it will take time to go through the list. Once at the end of this list we will start all over again for no big pharma co that got fined ever stopped. Look at pfizer.
As long the big pharma is awashed in all those $$$ as result of of high prices and extra sales as result of misconduct, this will not stop. The results of illegal activity are so fantastic (for lack of better word) and so seductive that no half-indecent big pharma exec. would give this up. Damn the fines and damn the bad publicity for they are nothing in BIGPHARMALAND!!
Drug Law Blog
I’m Your Pusher: Purdue Pharma Cops to Oxycontin Charges
Today is clearly not a good day at Purdue Pharma, which is being pilloried in the press and in the blogosphere after pleading to charges of misl[eading] regulators, doctors and patients about [oxycontin's] risk of addiction and its potential to
Melody
Corporate removal from the ranks of “citizenship” would be a start; criminal/civil liability for the PEOPLE who act in behalf of the corporation would be a good second step. The “death penalty” for repeat offenders would also be helpful. (NCAA violators have on rare occasions been given the death penalty. It impact the entire institution–not just the offending sports paradigm. Returning to the land of the living is tedious and of long duration . . . and even then, the stench remains. If BigPharma and medical professionals are forever talking about self-policing. I’d sure like to see some of this self-policing. Alternatively, maybe government is the only entity powerful enough to legislate such policies.
brenda bladgett
I can only think of disdain for this company. So long has gone by since the manufacturing of this fatal drug. I feel this company could never repay the public for what it has done. We have oxy addicts everywhere. I am in favor of the use of this medication if a patient is end term and end term only. I have seen countless oxy addicts struggling to regain their normalcy without success. Crime has soared, sick people being robbed for their medication. I think there needs to be definitely controls put on this medication. It should be used for the terminally ill only. Any Doctor prescribing this medication to people whom do not need it should lose their licensing.
Otto
The problem with these corporate lawsuits is that they don’t hold people criminally responsible. All they do is levy fines that only cut into their profits, some what. If the fines were enough to ruin companies they would actually deter.
The people that decide to hurt people for money should be charged with assault (multiple counts) and imprisoned. It should not be simply a matter of paying fines that do not even erase the profits. There is no deterent–maybe Congress should be held accountable for allowing such abuse.
On the same topic, tobacco she be illegal. It kills 400,000 Americans each year. Teens get hooked because they want to “fit-in” and because of their natural development, they feel invulnerable. I forget the term but developmental psychology says that the trait that makes it so teens feel invunerable is something that remains until around age 20.
Thats the rub. People say that it’s their (smokers) own fault if they get sick but it isn’t. If a teen wants to fit in (need for affiliation), and their friends happen to have gone down that road, they are not in a position to easily
make the right choice. By the time they know what they have gotten into, they are very addicted. Some will be able to free themselves of the addiction but most can’t (some people are more severely addicted than others).
Tracey Wilson
The Sackler Family and the sleaze bags get off again. All the cases that were settled and thrown out BEFORE these scumb bags pleaded guilty? Isn’t anyone just a bit suspicious about the order of events here? And no jail time? How does that happen? It’s called money and lots of it. Just google Sackler and see why. They own Purdue.
Lt. Thomas Schmidt
I have been on Oxycontin for over 4 years and without it I could not continue my work on the force. I have seen it destroy some of my co-workers though. They would confiscate dealers without arresting them just so they could get their hands on those pills. Turning into drug addicts like the ones they are supposed to be arresting, they spread their filth all over the department. Rest assured this is happening in all corners of the USA and other nations Im sure. What kind of law enforcement do we have when a drug like Oxycontin has brought these otherwise law-upholding men/women to their knees. I know that;s no excuse but this should be looked in to. Not to mention, do you think the DEA is exempt? Hell no, I’ve seen it. They are some of the worst, stealing the dealers drugs just to throw a party and use it themselves. What kind of oath did they take? a HIPOCRITIC one I believe. HA! I am proud to say I am turning these people in and I have compiled a list of over 60 LEO and DEO that will be getting the traditional BOOT.
thats all for now, pray for their families. Most of them know but won’t expect the upcoming scenario.
I thank God every day I take it as prescribed and that is all,it is a miricale drug if taken correctly. Thr problem is that most do not ue it correctly. Help me clean up the law. Help me, I can do it myself. I am starting though, wish me strength and pray for me as I am sure I will be out of a job .
Mark Brewer
Schmidt is an idiot if he REALLY thinks that oxycontin will not destroy his life. I know it takes away the pain but does this moron have any idea what his liver and kindneys are going through? I was on this shit for over four years and my Dr. (Dr. Feel Good) had me taking over 500mg a day. I admitt that I should have went through detox earlier but once you start to feel withdrawls you just go back and take another pill. My Dr. told me I didn’t need to be weened off of the meds, it was just in my head. Now that is one BITCH that needs to lose her license, or better yet, have one of her loved ones become addicted and have to watch withdrawl first hand. I was so desprit to get my life back together that I checked into a VA hospital, (everything you have ever heard about VA’s is untrue, it’s worse) where if you don’t or should I say can’t get up out of bed to get your meds or even eat, you are just shit outta luck! Well I’m not going to go on and on about my problems since mine are no bigger than yours, but in the end, I lost my children, my marriage, my house, my job, and most of all my spirit. Mark J. Brewer Hanoverton, Ohio
Marianne Skolek
Ed Silverman — I testified against Purdue Pharma and Friedman, Udell and Goldenheim at their sentencing in Abingdon, VA on 7/20/07 and before the Senate Judiciary Panel in Washington, DC on 7/31/07. If you would like to post my testimony before the US Senate against the 3 convicted CEO’s and Purdue Pharma, please let me know and I will forward it to you. I have also prepared the necessary paperwork to have Udell disbarred from practicing law in Connecticut and NY since he is a convicted criminal whose actions caused death and addiction in epidemic proportion throughout the country. Goldenheim’s medical license revocation paperwork is being prepared now. Marianne Skolek
Melody
Marianne–
I went to the Senate Judiciary website and read your testimony (and that of others). Thank you for your sticktuitiveness and pursuit of justice. I wish there were whistleblowers who would act “ahead of the curve” instead of having to wait for such tragedies to occur before wrongdoing is addressed. For others who want to read, here’s the link:
http://judiciary.senate.gov/hearing.cfm?id=2905
Dana Bentley
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http://www.avatarsofjustice.com/
Nancy Davis
I feel for anyone who is addicted/physically dependent to this drug, and any other opiate for that matter. Doctors don’t have a clue what to do when the patient becomes addicted/physically dependent and needs help. Nor do they want to talk about becoming physically dependent or withdrawals. They just continue to write the prescriptions and send you on your way!
With Oxycontin it is not just a matter of abusing the drug to get high, patients become physically addicted and cannot stop taking it without becoming deathly ill.
My daughter was prescribed the drug in order to manage pain. Her comment to her doctor before the first prescription was written in the year 2000, was that she did not want to be given anything that she could become addicted to. Her doctor’s comment to her was, “you cannot be concerned about that, we need to control your pain”. (I was present during this conversation in the doctor’s office). The longer she took the drug, the dosages kept increasing, her physician even sent her to a pain management center. They also kept increasing the dosages. To quote the physician @ the Pain management center,… “Oxy is better than percocet because the patient does not feel the high’s and low’s…just keeps a steady level of drug in your system. The drug has just been given a bad reputation because some chew it to get a quick high”.
My daughter soon became physically dependent on the drug, countless trips to the ER when she ran out of her medication, deathly sick, uncontrollable vomiting.
To make a long story short, she no longer had control of herself, as the drug was controlling her. We even tried detox centers, who convince you that in (5) days of Detox, you are fine. Of course they provide subutex or suboxone during the course of the (5) days, patient feels great, until they get home and this medication wears off.
1 1/2 years ago my daughter ended her battle, (of 6 years), by taking her own life at the age of 29.
There should be complete counselling and warnings up front by prescribing doctors,(describe addictions and what it’s like to try to come off the drug).
The Doctors must also be held accountable to direct the patient for professional care when the patient asks for help in getting off the drug.