Healthy Skepticism Library item: 19136

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E
St. Jude Whistleblower: ‘This Wasn’t Patient Care’
Pharmalot 2011 Jan 28
http://www.pharmalot.com/2011/01/st-jude-whistleblower-this-wasnt-patient-care/

Full text:

Last week, St. Jude Medical agreed to pay $16 million to resolve allegations the device maker used post-marketing studies and a data registry to pay kickbacks to induce docs to implant pacemakers and defibrillators (read the settlement). The allegations were contained in a qui tam, or whistleblower lawsuit filed by Chuck Donigian, who worked for St. Jude as a technical service specialist between 2004 and 2007. His job was to provide support to the sales force by helping to market the devices, visiting cath labs and operating rooms, and assisting with paperwork for enrolling patients. But he didn’t like what he saw – St. Jude staff would sometimes fill out paperwork for follow-up visits instead of docs, sign forms on behalf of physicians, patients were enrolled improperly and scientific posters were allegedly ghostwritten. Then there were bottles of wine and sporting tickets given some docs. In all, St. Jude allegedly handed out millions of dollars around the country to bolster use of its devices. For his trouble, Donigian will receive $2.6 million, plus interest, but before paying his attorneys and taxes. We spoke with him about his experience…
Pharmalot: What behavior prompted you to blow the whistle on your employer?
Donigian: When I started realizing they were using studies as a sales tool to get business. At first, I was kind of excited to get involved with clinical work. But when the patients weren’t meeting criteria for inclusion in the trials, I started raising questions. But they told me to enroll anybody and everybody or the physicians weren’t going to implant the devices. That’s when I started realizing we weren’t doing science.
Pharmalot: What happened then?
Donigian: At first, I brought it up with my team members and was told by manager that it was my job to do this. So I later called the corporate hotline and spoke with an attorney, who said he wouldn’t speak with me unless I told him who I was. He said I was protected. And then he went on to tell me we’re not supposed to do the paperwork. He proceeded to contact my boss to let him know I was raising hey…And so during my review in April 2006, I sat down with my regional manager and he brought up all my conversations with corporate, the attorneys. He wrote in my review that I was insubordinate and questioning what was happening. I was constructively discharged. I received threats.
Pharmalot: Was there a particular episode that formed the tipping point for you?
Donigian: I started complaining in the spring and early summer in 2005. I questioned stuff with my team members. And in August or September of that year, one of the sales reps told me that a physician in our area was presenting one our studies at the Heart Rhythm Society meeting. It was about data for a pacemaker. What raised my concern was that he wasn’t involved in collecting the data and they were presenting it as science.
Pharmalot: How so?
Donigian: There were patients who were put into the study that didn’t meet the criteria… For a-fib, they would want a patient with a history, but some patients may have had complete heart blocks, but never had an a-fib. This took the focus off the study. Yet 100 percent of the people seen were put in studies. Never once was I called to say that patient didn’t meet the criteria. The physicians got paid an extra $1,000 to $2,000 for each device and putting them in the studies. There was concern that if St. Jude wouldn’t pay for them for the device, some other company would. I was pretty much told if we don’t pay doctor x for participating in the studies, another company will… Part of the problem was that the sales force was in chart of trials. There was no separation.
Pharmalot: Why did you bother, though?
Donigian: I felt bad for the patients. Some studies were requiring them to come in more frequently than if they weren’t in the study. They were incurring extra costs. Meanwhile, the physicians would still bill for patient visit and would get paid by the company for follow-up visits. But grandma would have to come in during the snow. They just wanted them to come in more frequently so they could collect the data…. When I went into that (job performance) review, I realized my time with the company and industry was limited. So I started looking on line to see if there were any protections for employees who report (problems) internally and that’s where I came across qui tam and Nolan & Auerbach.
You see, I’m a registered nurse and I understand physicians and nurses are supposed to practice evidence-based medicine and if that evidence is tainted, we’re not giving the best care to our patients. I’m a caretaker. And this (activity) had nothing to do with helping patients or making better patient decisions. It was all about physicians padding their wallets and a corporation padding their wallets. Not all doctors practice like this. There were a few that did. And a bunch that don’t. I don’t want to get the word across that all physicians are in this boat.