Bristol-Myers Pays $515M To Settle Charges

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fraud1.jpgThe drugmaker agreed last December to settle charges of giving kickbacks to docs and overcharging the government, but now the bill has come due. And this includes signing a 5-year corporate integrity agreement (here it is).

The US Attorney in Boston, Mike Sullivan, charged Bristol-Myers with illegally compensating docs to induce them to prescribe oncology meds between 2000 and 2003.. The kickbacks included consulting fees, advisory board payments and travel to “luxurious resorts.” And there’s more: The drugmaker’s Apothecon unit was charged with paying retailers and wholesalers to stock its drugs; there was off-label promotion of the Abilify schizophrenia drug for use in kids for dementia-related psychosis, and Bristol-Myers also misreported its best price for its Serzone antidepressant under provisions in Medicaid..

Bristol-Myers directed its sales force to call on child psychiatrists and other pediatric specialists, and the sales force then urged physicians and others providers to prescribe Abilify for pediatric patients. BMS also created a specialized long term care sales force that called almost exclusively on nursing homes, where dementia-related psychosis is far more prevalent than schizophrenia or bipolar disorder, according to the Justice Department.

“Kickbacks are especially nefarious when they are used as part of a marketing effort to convince physicians to prescribe drugs for uses that the FDA has not determined to be safe and effective,” Sullivan said in a statement.

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  1. Nailed ‘em!

  2. So they settle this, fines are paid to the government, and what happens to the kids who were given Abilify under false pretenses? And Pharma wonders why the public has NO faith in anything they say.

  3. B-M is now a second member in the over-a-billion-in-fines club. Other members like Pfizer, AstraZeneca are coming close with mltiple hundreds of millions. Noticablly absent is Novartis that has managed to keep the DOJ off their back with a good coat of teflon that has worked for them, till now at least. Some of the charges and convictions we see here this company has done routinely for years. Not only in US but other countries too, one very close just north of the border. Luckily for this and other companies those other countries have very weak laws so they get away easily. Even those that got caught in USA. For Novartis to manage to escape this kind of fate in USA tell a lot as to their ability to cover things up. With the recent whistleblower out and few in the waiting things may change for them too.
    Imagine if all these big pharma wrongdoers to use the mildest word, did not get caught all that recovered money in billions would be in their pocket instead of peoples. By the same token, all those still not caught have all those not recovered billions in their pocket instead of ours. Are we going to go after them and make it right. One hopes.

  4. Dear Hypocrisy Rules,

    Doesn’t SP hold the all-time record for fines in the past 5 years? It seems they are already over $2.0 billion and there are several more investigations ongoing

    MD

  5. MD,

    Given their ignominious past, alledged corrupt present and probable fine-ladened future, they’ll no doubt pass everyone by leaps and bounds before it’s all done.

    FH and CC will stick their heads in the sand and look the other way until their precious SP comes tumbling down. Of course, they’ll probably have passed the liability onto some other unsuspecting company (Pharmacia’s pass to Pfizer on HGH off-label promotion) before the hammer comes down.

    CA

  6. CA,

    Virtually no doubt about it, Schering-Plough will hold the crown, but will King Fred and Queen Carrie still be there or will they have already abdicated?

    I. Agrre

  7. Good points by all. It seems it never ends for the big pharma. Some are more “productive” than others but those that have used misconduct and wrongdoing to enhance their profits can not stop. The answer is very symple, why not? The results of deliberate use of misconduct are so super-good and seductive that no one who ever experienced the high can give it up. Besides they are “playing” with company’s money so they do not risk much personally. Also no person has ever been fined or punished and if the corporate bosses say “just do it” why would they ever stop.My question re Novartis is based on my personal knowledge and evidence of thier use of these questionable means of doing business. So naturally I am always surprised when the others get it but not them. Again, imagine the money that is still out there for the people to recover. At least in USA you have a good chance to make progress. In other countries it would take a miracle for any of those already fined in US to get the same “deal”.
    Our group is doing something to change this in our own jurisdiction.

  8. Speaking bout NOVARTIS - they just managed to get Lamisil approved for Pediatrics. The package insert says it can cause Neutropenia and there is one case where neutropenia occurred and turned into full blown Acute Myelogenous Leukemia, poor little children - well I guess they can always take Gleevec.

    Hmm, pity in order to cure a fungus infection poor unsuspecting parents will not realize that they will increase the odds of causing leukemia in their Children. Me personally, I’d rather have a fungus infection….

    What is the world coming to?

  9. Someone - you think there will be a run on this?!!?!?!

    How uninformed are you? There are few weapons against fungal infections - and even fewer have ever been studied in peds.

    If your son/dtr has a life threatening fungal infection - you would thank them for doing this research with very little return.

    Think about how many millions of people have taken Lamisil over the years - and you are worried about 1 fluke case report?!?!

    Pediatricians are notoriously conservative - this will only be used in the hospital with serious infections of a fungal nature. You aren’t going to see Lamisil scrips like you do Amoxil suspension. MY GOODNESS when is more information about how meds affect kids a bad thing. WOW - you guys are militant about bashing pharma/traditional medicine for everything they do.

    Yes, I would rather have a fungal infection vs. AML. But I would also rather be cured of invasive cancidas than die from it. Again - that’s why it is called risk benefit ratio. Do you really think this will be prescrbided for ringworm in kids.

  10. Also, hate to scare everyone non-medical. But if you look up the PI of any drug, if you are uninformed you wouldn’t want to take it.

    Aspirin causes GI bleeds that cause 16,500 deaths each year (NSAID gastric ulcers)

    Tylenol causes liver failure when used incorrectly. OTC decongestants have been linked to heart attacks. Dextromethorphan has killed adolescents looking for a high. Everything on the shelf has some bad event linked to it.

    AND these are just the meds deemed to be safe enough for the public not to screw up and hurt themselves.

  11. No one is bashing big pharma for everything they do, just the unethical and sometimes criminal things they do to expand their profits beyond what normal positioning and promotion of their drugs (good, bad or ugly) would bring in. Just look at that list of offenders that paid many billions in fines cumulatively for doing such misconduct. It is not the scientists in this biz that atr the nasty ones. It is their marketing and sales types that keep inventing “new and more effective” ways to sell their stuff. In many cases they equate marketing with lying and cheating,. Someone should explain to them that is not the case.
    Any takers?

  12. Hey Todd,

    Hmm, OK, you’re right they won’t figure out how to get the schools involved and there certainly won’t be any intervention with the little children getting their little toes inspected for fungus because they don’t run fast enough in the gym?

    I mean after all they are already in the schools with ritalin…

    But, you’re right it is so much better to live in your naive little world….

  13. Hey Todd,

    You must be from R & D because you appear to believe in medicaine and science for the good of mankind. It’s the Big pharma dark side that makes everyone angry! Pushing drugs for off-label indications and using every unethical, illegal trick in the book, while exposing patients to unknown risk. If you get caught, just hire a bunch of lawyers, admit no wrongdoing, pay a huge fine that comes from the shareholders pockets, protect the big shots, and laugh all the way to the bank.

    They deserve all the negative press they get and more. In the news this morning is Lilly - another company with a long line of violations. Why these companies can’t sell ethical pharmaceuticals ethically is the big issue. They’re just too darn greedy and simply can’t help themselves!

    MD

  14. Someone and Maryland,

    In my naive little world ADHD drugs are overprescribed because parents are awful in this day and age and take their kids to get medicated because it is easier than instillin discipline at home.

    Fungus and antifungal agents won’t be overprescribed b/c parents won’t demand it. Teachers won’t complain about behavior problems. Look at what is driving these “unethical” scrips - patients or parents. Depression, psychoses, other mental issues are subjectively diagnoses at the urging of the patient side of the relationship. If people didn’t come in and demand they get Cymbalta because they saw it on TV and it might help they wouldn’t get it.

    Businessed do that advertising because they are allowed to, and it works. They are still businesses, this isn’t Cuba. Let me know in a year how many hundred of thousands of dollars the sprinkles have sold. But good luck finding that info as it will be such a small number it won’t make anyone’s annual report.

    In this day and age, if a doc prescribes a drug solely because of some “Off-label” marketing tactic, they are a MORON. And the patient is seeing the wrong doc. Do more research on your doc than on your car

  15. Doc (MD) knows best. You are absolutely right about the dark side of big pharma. In fact I have seen it years ago, having spent over 30 years as drug rep, and documented it. In fact I have drafted a book with tentative title “Big Pharma, the Nasty” that deals specifically with the dark/nasty side of this biz. The main premise is that the nasty side (off label, bribes, lies, fraud etc) does not happen by accident or done by rouge employees. It is planned, deliberate and approved by the very tops of every big pahrma. If you like to see a sample go to cafe pharma and see it.
    As to off-label marketing tactics that docs should not follow, often they are not even told that what they are being “sold” is off label. Take a busy GP who has not time to check it out. He simply takes his rep’s word and advice.
    It is a nasty/dark pharma world out there. But it should not be that way.

  16. hypocrit,

    That is a great name for yourself. Why didn’t you have the morals to either be a whistleblower or get out of the industry? Have you been in the industry over the last 5 years with a reputable company?

    Anyone who tells me to check out cafepharma does not get any credit whatsoever. It is simply where the worst humans hang out to trade lies and awful, vulgar language. It is the same negative 8 people from each company on there. Also, in this day and age — do you really feel like docs trust reps at all? No, these guys don’t believe anything out of a reps mouth. Why do you think the arms race is over and people are cutting reps. — because they have oversatuarated and no one either sees reps or believes them.

    If a rep is not smart enough to know what is in their label, and believes everything they are told, they are equally at fault.

    Nice career though hypocrit. Stay in a seedy profession, document it after the fact, on things that happend decades ago. But then feel better about yourself because you “made a difference with my book”.

    Jamie Reidy wrote a funny book about carrying the bag, he didn’t make that much dough, I wouldn’t plan on this being your retirement. Although with 30 years in, I guess you have a great pension plan waiting for you. Nice job of screwing your employer after you are out instead of standing up for the right thing over the last 30 years.

  17. Yes, hypocricy rules, everywhere. It is the way of our “best” soci-economic system. Especially yours, in USA. Yes I did make a fairly good living in pharma biz ( not big pharma for while it was only pharma it was ethical, decent, gentile and very little if any corruption) that called itself “Ethical pharmacuticals” industry. When the mergermania turned it into the big pharma we see today some 15 years ago I turned against their ways and made every effort to prevent or stop the downward spiral. I followed my own co’s codes and rules and WBlew internally as per top wise guys instructions and encourigement, only to see myself out as soon as they got the whole story and finished with cover up and promotion of those involved in misconduct. It was hypocricy at the ultimate and at the highest level of this coorporation that is still untouched by DOJ or any other authority in the world. How do they do? They are the best in use of misconduct and cover up when it is exposed internally. If they were only as good in putting out drugs without having them withdrawn soon after the launch, my pension would be assured. This way I may have to go back into the pharma insanity but my chances would be somewhere around Peter Rost’s chances and you know what they are.
    As for CP, it maybe a crazy place but even if only 5 % is true what is reported there it is way too much for an industry that still dares to call itself “ethical”. Now there is your true hypocrisy.

  18. The fact that you go to CP, and believe that 1 in 20 posts are true tells me all I need to know. Good luck with the book, sorry you couldn’t make a difference while you were in the game. The rest of us out here will make up for your slack and do things the right way and hold our companies up to our standards.

    Internal whistleblowers is not where it is at - I am begging for someone to tell me to do something off-label. I will RUN to the FDA, as that 5% is my retirement. I think the industry knows that there are more people like me in this business than people who lie on CP.

    If after 30 years you may have to go back into the industry - you have obviously done something very wrong. That tells me more about you. If it isn’t something you are proud to do, why not find something useful to do that helps society? I look at this job as the ideal way to support my family. I and my company do things the right way. I use my personal time to make a difference in the world. It is amazing how much you can help when you sacrifice your time and money to help others.

    So you and Peter can think you have really made a difference and are changing the world. If thinking you won’t get rehired makes you feel better, good for you.

    You can think you worked for “ethical pharma” or whatever, but I am guessing they hired you as a “sales rep”. You can think it was really different, but it was and always will be SALES.

  19. What is with you Todd? Are you the one from one of the Seinfeld episods, Todd Gack? He was a wierd one. On one hand you say how you use this biz to support your family and and on the other none of your posting time is reflecting the work day of someone dedicated to his Co or biz. Ok twice you might have posted when you had an “early” quiting day and got on the computer right away to answer that “crazy” hypocrisy guy or anyone else you choose as target, as shown above.
    If you do work for a big pharma it seems to me you are just lurking in the dark waiting for that life changing order to sell off-label and you’d be rich. It ain’t that easy anyway and all the companies including yours and my X know how to handle it in all except most extreme cases when the “lurking guy” gets them. So you better get of your high horse and go out there and push their &^%@* they way tey tell you. By the way that ain’t selling either. Pharma sales reps if and when they do leave and want to sell in other busnesses need a lot of re-education to be able to sell “real” products. Some never make it in other industries for they have lost all their sales talent while pushing their &^%$ with up to 10-12 other reps in the same territory. That is your big pharma and I can assure you the classic ethical pharma industry was not like that. In fact not even close. If you deny it you are either too young to know and don’t want to listen as many young reps do, or you never experienced or seen the ethical pharma the way it was. And it was wonderful. Anyone here on this blog who does know would tell you the same. I bet.
    As for me, I neither need nor have to work in any let alone big pharma industry. And yes I will try my best to “help society” by doing the right thing and see my quest to the end to take at least one down, without having to lurke in the dark.
    This will take place in a “local” country where we have no such strong laws as in US. That is the biggest luck for my Xco. otherwise they too would have joined the mulit-mllion-fines-club, had this taken place in the good old USA.
    This concludes my “contribution” to this post. There are some other interesting targets to aim at, Todd Gack.

  20. Wow, nice Seinfeld reference. Since you aren’t US, I guess we will have to assume both countries work in different ways.

    I was in health care when your so-called “ethical pharma” days were going on. And you know what, I decided the people calling on me had better jobs than I had. So I have literally seen both sides of it. I have carried the bag, and now I have a different role in pharma. Degrees can get you moved up when you want to. So I work from home, not required to go out and pretend to work a full day. I still get out from time to time - both on my own and with reps. But the majority of my time is spent in my office ,the home office or with our key opinion leaders.

    Yes, everything changed. And everything will continue to change. Only the ones too old to change deny that. I understand you made way too much money doing what you did, and now think that age and wealth equate to always being right. Sound like anyone you called on? I actually liked medicine when I graduated. Things changed, I found a better way to support my family without selling out my soul and then complaining about it.

    I am just asking you to either admit you sold out your soul when things changed, or quit talking about how you are going to redeem yourself with your book on the dirty practices that everyone “except you” did in the industry. Doesn’t happen anymore, doesn’t happen in the US, at least it doesn’t in my company.

    Good luck with your smear campaign, please limit it to outside the USA. I really don’t care if you hurt your countrymen, but don’t hurt the reputation of hard working, God fearing, Americans trying to do the best they can to support their families.

  21. All right one more time. I have your picture and situation now. Do not want to be offensive to you for I think you have quite few miles on your company car. (They still buy you one I hope). Obviously we are on the oposite side of the issue, you supporter and apologist for the big pharma I complete oposite.
    As for your claim that big pharma does not do illegal, unethical and immoral things any longer, just go back to the top of this post and read the post by Ed. Maybe you are working for some prestine company not on this list or any list of offenders. There is a possibility that there is such a company. I remeber Astra when it was on its own was considered one of the most ethical comapnies and was not doing any corruptive things. Today as Astra/Zeneca I would not voutch for them. If you work for Novartis just wait for a while in US too. And of course it you work for a third Co that we don’t know about and their highly ethical ways, please let us know. I am sure everyone here would just love to know. There is always an exception and you are really lucky to have found it.
    By the way, the actions of DOJ that reslt in recovery of so many defrouded millions for the people (over 20 billions in last 10 years) is not all that bad. Perhaps some day it may contribute to your own national health care system so you can
    join the rest of us.

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