Heartbreak Of Psoriasis: Amgen’s Enbrel Tactics

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enbrel-3.jpgIn the fall of 2006, Amgen was worried about a key product - Enbrel, a biologic used to treat psoriasis and psoriatic arthritis. The med was a big seller, but hit a rough patch - sales in that year’s third quarter rose a mere 5 percent to $705 million thanks to increasing competition. And this was well below the 20 percent growth rate expected by Wall Street.

During a conference call with analysts, Amgen executive vp George Morrow expressed his frustration: “Enbrel is not meeting our expectations despite considerable effort.” Docs simply weren’t prescribing Enbrel as often as Amgen expected, and Morrow told analysts that week that the biotech planned a direct-to-consumer advertising campaign and other tactics to encourage patients to discuss the drug with their docs.

george-morrow.jpgWhich tactics? He didn’t say. But around the same time, former sales reps say Amgen sales managers began pushing them to promote off-label and to encourage docs to prescribe Enbrel to patients who may not have needed the drug. There are also charges that reps were told to pull patient files from doctors’ offices, orchestrate letter-writing campaigns to patients and insurers, and arrange and attend patient outreach seminars. These activities, which were made in complaints filed by former Amgen reps, allegedly involved patient privacy violations.

These activities have attracted the interest of the Senate Finance Commitee, the New Jersey Attorney General and the Florida Attorney General. So as the complaints filed by the former reps are pursued by investigators, might the trail lead back to Amgen’s executive offices?

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  1. Why do some activities attract the interest of prosecutors and others do not? Similiar activities conducted by other pharma companies are ignored by such people, directly or indirectly.

    Educate me on law and politics…….

  2. Hi Dan,

    You know the saying about the squeaky wheel? Well, sometimes, it gets the grease. Sometimes. That doesn’t explain everything, though, I’m sure.

    Cheers
    ed

  3. Thanks, Ed, I think.

  4. Maybe our A.G. Should pay attention to the Mass Drugging of New Jersey’s Children under our Foster Care System. We have a HELL of a lot of off label prescribing of antipsychotics to our most vulnerable population. Id like to Ms. Milgram show some “real” backbone!!

  5. Dr. Edward Lewis Tobinick, California would appear to have found a modern golden vein in finding new indications in the “off label” use of Etanercept(Enbrel). In case you missed the latest “research” published in the electronic - Journal of Neuroinflammation: http://www.jneuroinflammation.com/content/5/1/2
    Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration
    Edward L Tobinick1,2 and Hyman Gross1,2

    This paper received worlwide coverage as noted proudly by Dr. Tobinick in the INR site: http://www.nrimed.com/

    Link to Dr. Tobinick’s TNFMedicine website containing indications for off label use of Etanercept(Enbrel) with references going back to 2000: http://www.tnfmedicine.com/tnf/tnf_in_general_medicine/index.html

  6. Hi Snug,

    The most recent published research was really just one case study of an Alzheimer’s patient. I realize that the news heartened families, and for good reason, but further research would be useful to better understand the situation.

    Regards
    ed

  7. Although I do not recall the details, this scenerio/story sounds very familiar. However, I believe it involved a drug company other than Amgen. The obvious question to me would be to ask how drug reps. would possibly be able to access patient records.

    I believe the fine for such a HIPPA violation runs around $10,000 per incident. An effective way to prevent such abuse might be to levy these fines against the physician offices who allowed (willfully or not) the access. That should put locks on their file cabinets in a hurry.

  8. As earlier noted, my own dermatologist knew of this story and was appropriately outraged.

    Off-label promotion is certainly not “news.” But file-pulling, etc., starts to put this up there with the Neurontin scam.

    If docs were getting a piece of the action, they should be put out on the same ice flow.

  9. This addendum. In terms of direct marketing to pts, I was surprised at how easy this was.

    TAP had an arrangement with Rite Aid for a while in which pts on Prevacid would get “reminder letters” re: refilling their scripts. The letter would be from “your pharmacist,” and the small print would say that TAP paid for it and that they had no identifying info for specific pts.

    Of course, they didn’t need it as long as Rite Aid was willing to play ball. And this was not off-label.

    Always wondered why I stopped getting my monthly letter. Kinda’ enjoyed showing them to my students in pharm. policy course. Almost as good as the fake TIME magazine with the Celebrex cover.

  10. This is only the tip of the ice berg. Look below! With epo reps, they were going into dialysis clinics and looking at patient files. Nothing better then telling a rn to pump up the dose. But dont worry, now amgen is in bed with FMC. How about a little pillow talk. Guess what? medicare is paying for it all. The outcomes not so good, dont worry increase the dose for all your patients. Patient outcomes great, overfill great, reimbursement great, stock price great. Its all about patient care.

  11. Actually, I know of an incident must worse than this. Involving a well known cancer drug. The patients who were on the special access trial while waiting for approval were actually contacted post approval directly from pharma company and asked to take part in a marketing survey. This information was supposed to have been kept away from marketing. The sad reality is that many of the patients had died and their families were outraged. The same company then paid a large cancer fund raising organization to put out a magazine directly to patients that was completely written by the pharma company’s marketing agency. It was used to smear other cancer drugs. Patients who registered for the magazine did not/and many still do not know that the pharma company has access to their name, address and e-mail information.

    The drug works well, but it is not nearly as perfect as the company says it is. Additionally the marketing activity and practices supporting it are mostly highly unethical and illegal..

    The drug is outrageously expensive and the amount of “graft” being used to divert research and “buy” opinions in order to maintain the monopoly is amazing.

    We patients can’t wait to see when full disclosures and conflict of interest rules are fully implemented.

    The drug does prolong lives, but there is absolutely no transparency at all and some patients are being harmed by being left on the drug when it is clear they are no longer benefiting from it. They are being denied access to other newer drugs that would improve their quality of life and better manage their disease.

    Wall Street will have a field day…

  12. I guess nothing should surprise us, but it does….

    Predictably, after a urology appointment, I get an email from P-CAP, an “organization” for pts with prostate cancer (which I don’t have) funded and managed by a particular company/drug. My urologist, whom I like and trust, says there is no connection he can imagine.

    There must be a connection he can’t imagine, somewhere in the office.

  13. We are starting to see this pattern developing in South Africa. There is an upswing in requests to get bioogicals prescribed for various conditions off label.

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