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  1. #1
    ICN Founder icnmgrjill's Avatar
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    Are Physicians Being Bribed to Use Medical Devices

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    Whistle Blower Suit Reveals Ugly Side To Medical Devices
    Are Physicians Being Bribed?

    (January 31, 2006 - ICN Staff)

    Would you agree to have a medical implant if you knew that your surgeon was receiving large payments from the company as an incentive for using their product? Could you be sure that you’re getting a balanced viewpoint on the best products on the market today if your doctors’ opinion had been bought??

    Patients who have struggled with the decision of whether to have a spinal implant should take note of a Whistleblower lawsuit filed against Medtronic now sending ripples through the medical device industry. Initially filed two years ago in the United States District Court (Memphis), it was placed under seal until January 13, 2006. With the now public release of the details of the lawsuit, the accusations made by plaintiff and former employee Jacqueline Kay Poteet reveal a more controversial side to the device industry, the alleged compensation to physicians for doing implant surgery.

    The suit suggests that Medtronic, one of the largest medical device makers in the USA, made payments of $50 million in just four years to physicians doing implant surgery as part of a “bribery program.” One surgeon in Wisconsin was paid $400,000 for just 8 days of work. A surgeon in Virginia was compensated with nearly $700,000 in fees for nine months of work in 2005.

    While some industry and medical experts suggest that this is unethical and potentially illegal, representatives of medical device makers contend that the financial relationship is proper and necessary to help in the development of new products. US law is clear. Federal law forbids a payment that is intended to encourage a physician to use a company’s product.

    However, there is a loophole. The use of gifts and consulting arrangements are unregulated and, in the past ten years, may have escalated dramatically. In a recent article in the New York Times, author Gardiner Harris said, “The drug industry spends tens of billions of dollars a year to woo doctors, far more than it spends on research or consumer advertising. Some doctors receive a significant part of their income from consulting… other take regular vacations or golfing trips that are paid for by companies.”

    The questionable nature of these relationships has also attracted government scrutiny as well. Last year, US attorneys in Massachusetts and New Jersey issued subpoenas to eight device manufacturers (including Medtronic) in an ongoing investigation about the financial relationship between the companies and physicians.

    As a former employee, Jacquelyn Kay Poteet had access to a number of internal documents that may help her case. An e-mail message by a Medtronic lawyer in 2003 was submitted in the lawsuit that appears to confirm that company may have engaged in this practice. It said “When we are sending scores of doctors to a nice resort like this under the guise of training and education on our products, I think we need to be more careful and stick to the limits of our rules as best as we can.” In addition, Medtronic apparently kept detailed records of physicians who attended their events and created plans to target physicians who were not using their devices.

    Industry response has been lackluster and, apparently, temporary. According to a new filing in the lawsuit, payments made by Medtronic to physicians apparently slowed down in 2004 but resumed last year. One physician in Virginia made $300,000 in consulting fees in 2003, $75,000 in 2004 and a whopping $700,000 for consulting work in the first three quarters of 2005.

    Ironically, a group of physicians led by Dr. David Blumenthal (Harvard Medical School) suggested in this Month’s issue of the Journal of the American Medical Association that all gifts over a “modest value” to physicians be banned because they could have “negative results on clinical care.” They believe, however, that few will listen to their suggestions.

    One success story is Kaiser Permanente, which has implemented nearly all of the recommendations suggested by the article. Dr. Sharon Levine, associated executive director of Kaiser Permanente Northern California, was recently quoted in the New York Times: “We thought it was critical for us that our patients never had a doubt that the decision made about a drug or a device was based on the best interests of the patient and not the financial interest of the physician.”

    As a patient considering the use of a medical device, it makes sense to be aware of this issue. You certainly have the right to ask your doctor if he or she receives any industry money for doing this surgery. You can ask about their training in the use of the device and the number of procedures they’ve done previously. It’s also important to ask about other products available and what the pros and cons of each device may be. You can also ask about the role of the sales representative and if they will be present in the operating room. Are you comfortable with that prospect??

    We believe that you must also educate yourself about the device not only from company materials (such as videos) but also from other patients who have had the procedure. Ask your doctor if you can talk with other patients who have had success stories.. Take the time to search the internet for other patients who have had that device implanted, particularly those who have experienced complications. The FDA maintains an extensive database of medical devices that have malfunctioned or caused a serious injury. The MAUDE database is easy to use and searchable by company, product name and date at: http://www.fda.gov/cdrh/maude.html

    REFERENCES:
    Abelson, Reed. “Whistle-Blower Suit Says Device Maker Generously Rewards Doctors” New York Times, January 24, 2006.

    Harris, Gardiner. “In Article, Doctors Ban on Gifts From Drug Makers” New York Times, January 25, 2006
    Would you like to talk with someone about your IC struggles? The ICN now offers personal coaching sessions that include myself, Julie Beyer RD on the diet and Dr. Heather Howard on Sexuality. http://www.icnsales.com/icn-personal-coaching/

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    Please remember that the information on the ICN is provided with the understanding that ICN, its founder, staff, volunteers, and participants are not engaged in rendering medical or professional medical services. We cannot and do not give medical advice. Only your personal physician can do this for you.







  2. #2
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    WOW! This was my hubby's biggest fear when trying to decide about the Interstim. Thank goodness it helped and hopefully I wasn't one among the ones suckered into this as a money maker.

  3. #3
    ICN Member patricia1's Avatar
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    I have personally wonder this for several years. Since getting my first one in 2001. There are some doctors very gun ho to implant this device without trying everything as a last resort. And I dont think they are properly trained to deal with the after care should problems arise. I personnally have experienced this first hand when my orginal doctor would not help when I was having problems with mine. I also did not have health insurance anymore so go figure. Although I spent months reseaching before finally giving in, I only did so to try and help with my problems.

    I am saddened by this report. I know the people who do the medical products try and whoo the doctors into using their products, this one product can have serious side effects not being taken seriously by the doctor, Medtronic reps and Medtronic itself.

    Thanks for letting know this
    God grant me the serinity to withstand the days ahead!!!

    My myspace link...
    www.myspace.com/patricia_luvs_matt


    Patricia

    In Memory of My Father (Lawerence) 1/25/2007

    Procedures:
    Interstim Sept 2001
    1st InterStim Removal May 2005
    2nd Interstim Implanted May 2005
    2nd InterStim Removed March 2007
    Hysterectomy 1999
    Tubes Tied 1997
    C-Section 1996


    Me and my kids


    Taylor (my daughter) Me and my daughter My son Cody and Taylor

  4. #4
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    Wow! They're in big trouble!
    ,
    Karma

    Dream with the feathers of angels stuffed beneath your head - Clutch

    IC, PFD, IBS, Fibromyalgia, MPS, Migraines, Allergies, Scoliosis, Bi-polar, Vulvodynia......

  5. #5
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    Although I do not have one, I must say that this still makes me very angry. The treating physican should have nothing in mind except the best interests of his/her patient. This puts them on the same level as a car salesman who is recommending a product based on his commission instead of what would suit the customers needs the best. It would seriously make me question my doctor if I had an implant. I hope the AMA will jerk the licenses of these "professionals". I also feel they should have to refund every penny these patients have paid and be made to give them the money paid to them by these companys.

  6. #6
    ICN Staff ICNDonna's Avatar
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    Somehow, that doesn't surprise me. I honestly become upset when I read about someone who has just been diagnosed and already a doctor is wanting to implant an interstim.

    GRRRRRRRRRRR
    Donna
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    I am not a medical authority nor do I offer medical advice. In all cases, I strongly encourage you to discuss your medical treatment with your personal medical care provider. Only they can, and should, give medical recommendations to you.
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  7. #7
    Registered User peiti's Avatar
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    The news didn't surprise me a lot. Actually I Knew my doctor was paid for giving me the InterStim implant because he was doing the clinical trial.

    Doctors are taught at medical school that they should put patients' best interests in their mind, but I guess when it is about money, not everyone can beat this temptation. Somehow, it becomes a custom that most of the medical device or pharmaceutical companies pay a lot of money to doctors as a way to promote their products. And doctors know it is easy money. I just wonder what will happen if the companies stop giving money out, will that make the doctors angry or not wanting to use their products?

  8. #8
    ICN Member tigger_gal's Avatar
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    Physicians Being Bribed

    If these Physicians are Being Bribed they certianly are not interested in helping the patient. They actually should be listed as public information. I am very glad my doctor mentioned it to me one time, and one time only, he said when I was ready I would ask..... When I did ask, he told me all about it, and I researched for over a year.
    I really hate the fact hat these doctors got paid to promote it, and then screwed up the surgeries and patients had to pay for there mistakes.. I wish all the interstimers that had promles from day one would have had theres done by my doctor.
    'The will of God will never take you where the Grace of God will not protect you.'

  9. #9
    ICN Member patricia1's Avatar
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    I dont believe all problems come from the doctors themselves and them messing the surgery up. Mine was caused by car accidents that moved the leads. I knew that lead migration could happen but not to the point of the problems I had. Then the doctor did not want to help me. I believe he did not want to do anything because I had no insurance. He sure did not have my best intrest in mind. I feel he did a fine job on the surgery and the implantation of it, after all I had 6 months that were great, but his after care and not wanting to help me with a device, that at the time he was the only doctor in my city or within 3 hours of me could help me sucked. I do not think that the doctor who did my revision got any kick backs from Medtronic, and dont know for sure my first doctor did, but he was willing to put it in, before anyother treatments were tried and when I did do it I was his 3rd patient, kind of suspisous to me. Anywho back to my 2nd doc the revision was done at a teaching hospital, that cares for those without medical insurance or lack of funds to pay for medical care. So even without Medicare I would not have paid anything to have the revision done. He even had to go before the medical board to get this approved because it had never been done there.

    I just think more research should have been done in the area of IC itself before we all starting getting them.
    God grant me the serinity to withstand the days ahead!!!

    My myspace link...
    www.myspace.com/patricia_luvs_matt


    Patricia

    In Memory of My Father (Lawerence) 1/25/2007

    Procedures:
    Interstim Sept 2001
    1st InterStim Removal May 2005
    2nd Interstim Implanted May 2005
    2nd InterStim Removed March 2007
    Hysterectomy 1999
    Tubes Tied 1997
    C-Section 1996


    Me and my kids


    Taylor (my daughter) Me and my daughter My son Cody and Taylor

  10. #10
    Guest emilyrose197377's Avatar
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    I personally believe my uro is not the one being bribed becaused we exhausted every treatment before I had the interstim implanted for urinary retention.

  11. #11
    ICN Member ICLori's Avatar
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    This doesn't surprise me at all.... It makes me very unhappy though.

    I also have heard rumors of drug companies doing similar things with doctors.

    Blessings,
    Lori

  12. #12
    ICN Member vm's Avatar
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    Yes, they sure do, Lori. A friend of ours is a pharmaceutical rep and the stories he tells...... Dinners, trips, concerts, food - lots of "incentives" to prescribe the company's drugs to patients. I hate that.
    Kim

    Diagnosed August 2001

    Current IC meds: Elmiron (since 2001), Levaquin (one pill after intercourse to prevent UTIs), Effexor (for depression & anxiety)


    Past IC meds: Amitriptyline (Elavil), Hydroxyzine (Vistaril), Detrol LA, Lexapro (for depression & anxiety, but also helped my IC) (They all helped, but I was able to discontinue them.)

    I've been virtually symptom free and able to eat & drink whatever I'd like for about 8 years now.

    *****************************

    “We who lived in concentration camps can remember the men who walked through the huts comforting others, giving away their last piece of bread. They may have been few in number, but they offer sufficient proof that everything can be taken from a man but one thing: the last of the human freedoms -- to choose one's attitude in any given set of circumstances, to choose one's own way.” ~ Viktor Frankl

    “You cannot control what happens to you, but you can control your attitude toward what happens to you, and in that, you will be mastering change rather than allowing it to master you.” ~ Brian Tracy

  13. #13
    ICN Member icsonja's Avatar
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    No , I am not suprised either, especially as I try to learn more about interstim and its failures, this company is not an honest company, in my opinion, they have a number of lawsuits against them right now, and a huge recalll for a defevtive heart defibrillator and try to get any info from the FDA about interstim in the past 3-4 years, the Freedom Of Information Act (FOIA) passed by congress and is now law, is not abided to by medtronics.
    I know of other people here who have also been trying to get info from Medtronics using the FOIA, it is a joke, they havent reported and they dont respond to request even though it is the law.
    You know how everone tells you interstim is not for pain, or is not FDA approved for IC? Well I was going thru some of the literature I was given prior to my impant and the book I was given post implant and "reilef from pain " is mentioned many, many times.
    They even had a story of a woman with pelvic pain who voided 40+ times a day, her Doctors could not help her, but Suprise Suprise, implant interstim and voiding is normal and PAIN is gone. Lets set up and smell the garbage ladies, we have been had.
    WE let Doctors who were getting paid to use interstim, twice over, once from Medtronics and again from insurance our cash out of our pockets talk us into an untried device for IC patients, they used the "its safe for incontenince patients so its safe for IC too".
    I saw the relief from pain being repeated over and over, it was the line that sealed the deal for me. It is there in black and white, relieved her pain and voiding, I wasn't dreaming it, they were telling me it was working for pain, the company wouldn't lie to me would they?
    Yep I have been used and abused, I feel cheated. And I demand answers!!!!
    This company is so huge that our little group of upset interstim failures are a nothing to them, our phone calls are ignored, our concerns brushed aside. And the most common answer to a bad stim? Put in a new one! And we do it!!
    They are using our pain and desperation to make money and to hell with those who are damaged or in more pain than ever, its is always the same answer, do a revision, get a new stim....buy some more ..
    I am so angry, and I am going to try and channel this anger into a positive, so Medtronics here I come and I am PO'd and loaded for bear.
    I am out to make sure not one more human being goes thru what me and many, many others have suffered.
    please don't get mad at me, those who love their stim, I am glad you are ok, but you are the exception not the rule when it comes to IC and interstim, and I pray none of you begin to have complications, because it can be the worst time of your life, when your "lifesaver" becomes your enemy.
    Sonja
    Proverbs 17:17 A true companion is loving all the time and is a brother/sister that is born for when there is distress
    Support American Cancer Society Relay for Life
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    To read me and my family's story
    http://ic-network.com/patientstories/sonja.html
    Spinal surgery 04/06
    Interstim implanted12/04
    interstim removal 12/05
    Hysterectomy 1998
    Bladder surgeries due to hysterectomy,'98,99,00,01
    DXx with IC w/ Hunners 1999
    Chronic Pelvic pain
    Chronic fatigue
    Fibromyalgia
    Depression/post traumatic stress syndrome
    IBS
    Migraines(OOPPSS WRONG) DX on August 28 with focal seziures, NOw on Zonegram for seizures

    Treatments...Done 'em all, but still looking out for the one that is my magic bullet.
    Weekly or as needed instills w/ elmiron/lidocaine/bicarb

    Meds:various pain meds,Soma (muscle relaxant)
    Lunesta,Premarin,Clonazepam,Inderall,Relpax,Cymbalta
    and a few others I'm sure,depending on how good I have been on my IC diet.

    Trying to keep a positive attitude, in a negative world.

    Best treatment of all, Good Friends who Understand

  14. #14
    ICN Member Dixiefireball's Avatar
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    I for one am not shocked over this either. Matter of fact I read about this before it was posted here. I also sent the link to Jill, but she had already seen it.
    It really deeply sadden me how money can change a person so much! exp people that we trust in to care for our health.
    I honestly believe the pain clinic i was going to was doing this, but thankfully i had people to tell me Rhonda this isn't for pain! However I seen my neighbors sister have to go threw the trail of the interstim, because the Dr. told her he would not help her if she didn't try the interstim. If she didn't try it then she really didn't want help. So she had to suffer going threw this trail and lucky she got no nerve or any other type of damage from the trail, but yet had to suffer something painful for no reason. it just makes me flameing angery that people are put threw such just to fatten someone else pocket book a little tighter!
    I still believe its a personal choose but it needs to be fully research before going threw with it. People need to talk to both side and hear all the good and Bad stories. (however I've heard more bad then good.) but either way its your body its your right.
    I hope all these Dr that had done this wrong will be fully punished
    rhonda
    Medicine taken daily or as needed:
    1. Heaprin and Marcaine rescue installment 1 to 3x daily as needed.
    2. MS.Cotin 100mg 3x daily
    3. MSIR 30mg 1 or 2 every 4-6hrs as needed for breakthrew pain.
    4. Fentanyl 100 mg Change every 48hrs.
    5. Gentamicin 80mg install after each rescue treatment
    5 Leviquin 500mg self start as needed.
    6. Klonopin 1 or 2 daily as needed.
    7. Prosed/DS as 1 every 6hrs as needed.





    I have IC, but IC doesn't have me anymore!

  15. #15
    IC Friend Shars's Avatar
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    THANK YOU JILL SO VERY MUCH....I just sit and cry once again and did the day
    I had that article sent to me a few weeks ago. I am one amongst many with serious and permanent injury. It finally helps that this woman and employee herself as revealed this information. It also finally validates what many who have interstim and interstim gone bad already knew. I was so sadden when I was first sent that email the day it broke in the New York Times. I also was so relieved that finally this has gone public. I have the article and have read it in great detail. These doctors have received all kinds of things beside financial income to put these devices in. I also am so sadden as it had long been believed my surgeons did. It breaks your heart to know that so many are injured, damaged from the device, some are permanent, some are
    paralized from the waist down, some in pain forever, spinal cord injuries and so forth
    due to this kind of actions. It makes me say even stronger than I have always said before....please do not consider your rep your doctor. The reps are also very involved in this and they are not medical personal. Please go directly to a doctor for any and all of your questions. Please let the doctors do your reprogrammings or a highly educated person on his staff. Please when things go wrong focus your phone calls to your doctor or emergency room. To have so many end up with serious damage due to this is just so unfair. To have it change your life forever is just so unfair. To take control of what may be happening with you with this device is a positive thing. For you to make the decision that only a doctor will attend to you is a postive thing. To demand if things go wrong and want to see a doctor is alright. To demand that the device comes out if your having problems is alright. It is your right. To pay someone to do these and to keep them in a patients body is wrong. It is against the law. Therefore these cases are before the Justice Department for investigation. They are as all know called..and the article says this also..."Kickbacks." Being a person with a serious spinal cord injury due to my surgeons and Medtronic and having my life forever changed due to this kind of behaviour really breaks your heart. It has long been thought by many that knew this was taking place, but now it is finally in the open and has gone public. I know myself I was very grateful to see this as it may cause others to stop and think before they agree. However as being one with permanent damage and knowing many others also...I know this is very painful to know this happened all on the basis of kickbacks. Yes please do your research and Jill I cannot thank you enough for printing this. It is a very important added informative article for those that do not know or have refused to think anything like this could happen. It is extremely important for all involved as it shows that, "YES", there are serious problems financially.
    I really thank you and thank you for all of us with damage for putting this on the boards to also let people know here is yet another issue and problem. I know several that would thank you also. I also know the pain of knowing someone took money,trips,and far more that I won't mention at my expense and others with patients bodies is extremely disturbing and painful. To know it has gone public and more will follow these article is about time.
    At this time it is my understanding they cannot name the doctors involved in this.
    Thanks again from the bottom of my heart.
    Shars/Dusty
    Dusty/Shars

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