By Ed Silverman // January 3rd, 2013 // 8:54 am
From November 1990 to December 2005, Jill Osciecki was a sales representative for Amgen , mostly in the Midwestern US, where she promoted the Aranesp medicine that is used to treat anemia caused by chemotherapy and chronic kidney disease. However, she was one of a handful of Amgen reps who eventually chafed at allegedly illegal marketing tactics that have now become a familiar refrain in the lore of pharmaceutical marketing over the past two decades. Last month, the biotech paid $762 million to settle civil and criminal charges of off-label marketing and paying kickbacks (back story). The US Department of Justice found these practices induced physicians to use Amgen (AMGN) medications unnecessarily when lower-cost alternatives were available, causing federal healthcare programs such as Medicare and Medicaid to overpay. We spoke with Osciecki, who wore a wire during numerous meetings with her former Amgen colleagues, about her experience and why she decided to go to the feds…
Pharmalot: What prompted you to become a whistleblower?
Osciecki: I didn’t understand all the ins and outs of a qui tam or whistleblower lawsuit. I’d actually gone to the government first to report this activity before I filed this lawsuit. But the morale at the company was extremely low. My morale was low. People were being fired all over the place. This was in 2004. The culture had changed very dramatically after a managerial change. Amgen had been the kind of place where people loved to come to work, but then the management change made it miserable. But there wasn’t necessarily any place better to go in terms of the pharmaceutical industry.
So people were trying to make the best of it. But I’m a very stubborn person and I wasn’t likely to quit. I felt I may very well be fired as other reps had been. So I knew that if I ever intended to do anything about what I felt was unethical behavior, I had to do it while I was still at the company. I mean there were other things I could do (for a living) even if I got blackballed. I had a master’s (degree). There was a family business.
Pharmalot: What was the tipping point for you?
Osciecki: I’d seen a couple of times in the company where all kinds of policies, HR policies, were ignored. One of the things that put me over the top was an unwillingness to enforce some of the HR policies. One person was retaliating against me because I responded to the company after being called about potential discrimination in our work group. I reported that. They sent me a letter saying they investigated it, but they had not done that at all. I felt they were rotten to the core. They didn’t follow their own policies and I was fed up and experiencing retaliation.
Pharmalot: I see. And what about Aranesp?
Osciecki: We all knew what they were doing is illegal. The quickest way to get fired was to not hit your numbers and the only way to hit your numbers was to compete as everyone else was doing, which was to sell drugs through illegal mechanisms – promoting off label. [EDITOR’S NOTE: The feds accused Amgen of illegally promoting Aranesp at unapproved doses that were larger and less frequently administered, and also promoted the drug for treating anemia caused by cancer, regardless of whether a patient had been prescribed chemotherapy. The FDA determined this increased the risk of death.]
Osciecki: There were also the spread marketing techniques (in which Amgen manipulated pricing so that physicians could bill higher reimbursement rates to federal healthcare programs, such as Medicare and Medicaid). I was disgusted with that. It was clear that this (marketing) was not about safety and efficacy. It was all about getting reimbursement levels from Medicare. That’s all that the company cared about. Once we got reimbursement, then all restrictions were off. We could talk about how much more money doctors or their surrogates could make.
Pharmalot: Can you explain that a little? What wasn’t kosher?
Osciecki: Two things are not kosher – getting a compendia listing is supposed to be based on a broad overview of the literature and reflect accepted medical practice supported by peer-reviewed journal articles. Amgen had one, 30-patient study, which was not placebo-controlled, and took it to a compendium and convinced them to list it for approved use. The second thing is promoting or advocating for reimbursement of off-label use. And we had a clever way of getting around it. We were able to provide info to physicians in response to unsolicited questions. So we’d show them info on the disease state and we prompted them to ask questions about whether Aranesp could be used for anemia of cancer.
Amgen knew what the legal requirements were for providing reimbursement of off-label use. But there was not even a published study, just a poster from ASCO (the American Society of Clinical Oncology). That should have been a red flag. It was not peer reviewed. But once it’s in a compendium, they went around to cancer specialists. It was a huge end run around FDA approval.
Pharmalot: You portray this in the lawsuit as a rather widespread effort…
Osciecki: There was a national meeting where they rolled out the entire plan. There were also pre-meeting materials and working materials that we all had to read. You know, we’re talking about studies with glossy slides. Everyone had a role in this – marketing managers, scientific liaisons. There was a push to have anemia for cancer added as a reimbursable use of Aranesp. And once the listing was in that compendium, you’d have to get Medicare directors to change coverage documents.
Pharmalot: And the big competitive threat was (J&J’s) Procit, right?
Osciecki: We were aware of Procrit studies where patients had died and asked experts who said there was concern about providing (Amgen’s) Epogen in these patients, which could feed the tumor. I knew scientifically there was an unanswered question… Was it really even safe to use an ESA (erythropoiesis-stimulating agent, such as Epogen or Procrit) in patients who were not being treated with chemotherapy? There were large, placebo-controlled trials that had been done with Procrit. It’s almost the same drug as Aranesp and had shown an increased death rate in a controlled group versus a placebo group in anemia of cancer setting. The question was: Why were more patients dying on the drug? It was in the back of my mind that placebo-controlled studies showed a higher death rate and we were pitching a non-placebo controlled study to get a compendia listing and now all sorts of people would be taking it. It was risky.
Pharmalot: But why did you go to the government before complaining internally?
Osciecki: I was afraid. I had seen Amgen either punish people who expressed concerns or fired them out right. So I’m not going to risk that by raising this issue. It’s too big. I’m going to provide evidence to the government. Originally, I called and couldn’t get anybody on the phone, but I did get a call back from an agent and set up a meeting at a government building. It was a hole in the wall, a very unimpressive office. This was an OIG agent I met with (from the US Department of Health & Human Services Office of the Inspector General). They weren’t interested in a rogue district manager, though. They were interested in anything that would involve a regional manager or higher officials, or things that took place at regional and national meetings. I showed them evidence and was asked to get more evidence. As part of that, they asked me to wear a wire. I decided that I had to go to a higher authority. I thought the company was rotten to the core.
Pharmalot: It must have been stressful wearing a wire.
Osciecki: I did so on 13 different occasions. Sometimes I did it for a full day or multiple days. There were lots of logistics involved. I had to meet agents at various times each day to get new batteries and recordings changed out. It was quite stressful. There were special meeting places. What I was most concerned about was (creating noisy) feedback from the mechanism I wore. At one point, I went through a medical detector at an airport and the wire set it off. But luckily, none of my coworkers were with me.
There were times I was disappointed that I wasn’t wearing the wire on certain days when I heard certain things said… I also remember that one of my coworkers accused me of being the type of person who would report illegal behavior to the government. So yes, that was stressful. But I knew the financial incentives involved and, as a result, that off-label use was increasing the amount of money that the government and individual people were paying. I knew someone who was paying a $2,000 copayment for one shot. This was a real hardship on people. And I really wanted to stick around and do what I could.