Whistleblowers are a rare breed. What drives them? Beloved by Hollywood, are they heroes, saints, publicity seekers, or are they simply obsessed? The drug industry has seen a number of high profile whistleblowers come forth recently. At best, theyve saved lives, but even when they havent changed the status quo, theyve managed to open up discussion about ways to improve an extremely secretive industry.
But why do whistleblowers do what they do? The costs to career and personal life are extremely high, and the fiercely competitive drug industry, unforgiving. Consider some recent cases: in 1998, Canadian researcher Dr. Nancy Olivieri disclosed issues with a drug being developed by Apotex. She was removed from her post, but later reinstated and praised for her service to the public. Six years ago, FDAs Robert Misbin complained about the dangers of the Type-2 diabetes drug, Rezulin. He wound up resigning from the Agency, after he received his first negative performance review. The writing was on the wall, he said at the time. In 2004, Dr. David Graham, Senior Drug Safety researcher at FDA, blew the whistle on problems with the testing and approval of Mercks drug, Vioxx, as did Dr. Eric Topol of the Cleveland Clinic. We read in the press of Dr. Topols being demoted since then.
But pharmas whistleblowers arent all researchers. Last May, Mark Livingstons case against Wyeth Pharmaceuticals was heard in Greensboro, N.C. court. Livingstons lawyers invoked Sarbanes-Oxley, traditionally used for accounting fraud, to allege violations of good manufacturing practices at the Prevnar vaccine plant in N.C. Merck had a completely different story to tell, and Livingston lost his case, but plans to appeal. At the heart of his case, he says, was a question asked by someone who worked in the facilitys quality assurance department: Are we about saving lives or about making money?
What makes whistleblowers persist in their missions? Generally, by the time their allegations become public, theres no turning back. The die is cast.
So what would it take for a pharmaceutical marketing executive to blow the whistle three times, on three separate employers? Today we interview Peter Rost, an M.D. who has spent the last 20 years working in pharmaceutical marketing.
His story began six years ago when he headed up marketing for Wyeths Nordic division. Dr. Rost had noticed a pattern of tax evasion and expense account padding involving some company executives working outside of the U.S.
Rost blew the whistle, but soon found himself transferred across the ocean to what the New York Times described as a windowless office in Philadelphia and greatly diminished job responsibilities.
He resigned and sued the company, moving the following year to Pharmacia, where he was hired as vice president of marketing for a product line focused on Genotropin, synthetic human growth hormone, a controversial drug and the lynchpin to boomer-targeted anti-aging fountain of youth therapies.
Pharmacias sales team was promoting the drug for unapproved uses, or practicing off-label marketing. Salesmen were also offering direct bribes to doctors and distributors and all-expenses-paid junkets.
The next year, an investigation was launched, and Pharmacias marketing director was dismissed. Yet, Rost alleges, the practices continued, as if they had been ingrained in the sales culture.
Two years later, Pharmacia was bought by Pfizer, and Rost continued to bring up these issues by that time, he was reported as alleging, 25 to 30% of childrens prescriptions and over half the adult prescriptions for Genotropin were being used for off-label purposes. His lawyer informed the company that Rost would be filing a qui tam action suit; at Pfizers request, the Department of Justice launched an independent investigation.
Then, starting in 2004, Rost started to speak out about high drug prices, advocating re-importation of drugs, testifying before Congress and appearing on the television news show, 60 Minutes.
Over time he found himself increasingly isolated at the company. Ultimately, his email and cell phone were cut off, and he says he was spied on by hired detectives and harassed by lawyers.
Last year, Pfizer fired Rost, who has responded with a wrongful termination lawsuit.
He has also gone on to become a blogger, first on the Huffington Post. Some of his posts were bitter diatribes against Pfizer and its then CEO Hank McKinnell; some were on topics completely unrelated to pharma. He may have earned a reputation, among some, as a lightweight by blogging about his student days as a model, or a married friends love affair. But he is a marketing specialist after all he had studied blogging as if it were a science, blending topics surest to increase readership and using IT to analyze his audience, sometimes to a frightening degree, even disclosing some information on visitors. He ultimately discovered a troll on his blog, actually a member of the sites IT staff. He now blogs privately and has published a controversial book entitled, The Whistleblower: Confessions of a Healthcare Hitman.
A great deal has been written about Dr. Rost, both positive and negative. While praised by some, he has also been accused of being relentlessly self-promotional, and a serial or professional whistleblower.
His book has received quite a bit of publicity, but we wanted to get a better understanding of what drives this complex figure, and to ask him a few tough questions. Is he an altruist, an egoist, or a bit of both? PharmaManufacturing.com contributor Ed Silverman interviewed Dr. Rost at his home in New Jersey earlier this month. And so we present Peter Rost, in his own words.
E.S.: Why are you suing Pfizer for wrongful termination? You were terminated last year. What led to that?
P.R.: Very often, one thing leads to the next. Id hoped to avoid this situation, but couldnt, in the end, because of Pfizers actions. I was trying to work with the company for over a year. Some things they took care of. Some things they didnt.
After I outlined the situation in writing, they responded by writing that they would fire me. This is such a basic thing how you dont interact with someone who brings forward troubling information. Then things got quiet and they kept me on. I didnt know what would happen. But the meetings with Pfizers lawyers became very hostile.
So in the beginning of 2003, I contacted Pfizer in writing to make sure they understood what the concerns were here. They responded that theyll fire me. It was a bit of a strange response. Also they didnt tell anyone else at that point that theyd fire them. They waited until the actual acquisition (of Pharmacia) took place. And thats when I got my first indication that people were not too happy about what I discussed with them and they took a very hostile approach.
E.S.: By mid-2003, Pfizers acquistion of Pharmacia was complete. You remained with the company, but isolated in your office in the New Jersey suburbs. Other Pharmacia employees were leaving laid off, taking other positions. You got push back. You pursued the qui tam whistleblower litigation. You wrote in your book that you were isolated in your office. You werent sure who to report to.
Meanwhile, you pursued your stance with the price of prescription drugs and went public and got a national profile. This takes us into 2004 and 2005. At this point, though, Im wondering why did you remain with the company? You dont have any responsibilities. You dont know who to talk to, youre sitting by yourself, youre isolated. People are taking off. You have no interaction with anyone inside the company. Why stay? Why didnt you move on?
P.R.: I wouldve loved to have moved on. Like everybody else, I was doing lots of interviewing. We didnt know what would happen when Pfizer took over (Pharmacia). None of us really knew what would happen. I had a great CV and my results were, literally, among the best within all of Pfizer when they took over. If you looked at my actual sales versus forecast, versus budget. But my interviewing came to a very sudden halt. Suddenly, interviews were canceled. Things grew very, very quiet in 2003. And thats around the same time as the newspapers started to write about the Wyeth situation, my prior employer, where Id filed a lawsuit and the case had been dismissed to the mutual satisfaction of both parties. Once the papers started writing about that, interviews stopped abruptly.
E.S.: So youre saying the reason you stayed hidden away in the suburbs, working for Pfizer, was you didnt feel youd have an opportunity to get another job because of what you spoke about publicly about pricing and your reputation in the industry?
P.R.: It wasnt like I didnt feel I could get another job. I worked very hard at continuing the interview process. But once it became known about the Wyeth situation in 2003, basically, all interviews shut down. Completely. I continued to try to look for another job no one wants to sit in an office with nothing to do. But things got very, very quiet.
E.S.: So that brings us to late 2005, when your employment with Pfizer ended. For the past year and a half, youve been busy with other things. You continued the litigation, but you also got a high profile blogging. Why did you do that? And not do something else in health? You have an MD degree. You couldve pursued something else, perhaps in public health. Why did you pursue blogging?
P.R.: It was almost for fun, something to try out. I have an MD degree, but I havent worked as a physician for almost 20 years. It wouldve been very hard to go back into medicine. In addition, my degree was from overseas. I wouldve had to take tests all over again. It simply wouldnt work for me to go back to work as a doctor. And the companies havent been very interested . . . So far, nothing has materialized. Im looking in a very broad area. Ive had some discussions, but nothing has come through. And Ive come to realize people are probably nervous about someone who stands up and speaks about whats going on. So the only remaining avenue I saw was, actually, if I could support myself in a more independent manner. For instance, writing. Its not a situation where somebody has to hire you, especially the drug companies seem very afraid to do, despite my performance.
E.S.: Can you mention which agencies or non-profits youve talked to?
P.R.: Ive had some discussions with Canadian pharmacies, but nothing ever moved forward. Ive had interactions with non-profits, when Ive been invited to speak. But nothing has been forthcoming.
You have to realize that all of the money, and most of the employment, is in the private sector. You have a lot of people who do volunteer work in non-profits with little or no pay, with no funding. The drug companies have all the money and control. With all the opposition you see in the debate about whats going on, well, youd think theres another sector out there. But it turns out, most of those people do it for free or do it with extremely little money. It doesnt offer regular employment. Id expected, when I first started looking, that thered be more but so far, I havent found anything. And I have legal obligations and personal obligations, taking care of my family. Thats why I started to write and build something new. Basically, I was forced into it.
E.S.: How do you support yourself?
P.R.: Right now, I hope, a little bit of money will come in from the book. Ive also just started working with a law firm as a consultant on pharmaceutical matters. And that may also have potential for the future. I dont know how itll work out.
E.S.: Do you see yourself testifying as an expert in court?
P.R. Possibly. Yes.
E.S.: What do you like about the blogging and to what extent do think it helps your situation, your career? By the same token, youve become a lightning rod your public statements about pricing, your battle with Pfizer, which has belittled some of your blogging. To what extent has it helped your cause? And to what extent has it hurt your cause?
P.R.: Id like to back up a bit and talk about another matter that may be important: the reason why I spoke out about lower-cost drugs. I always had the dream and objective of one day running a pharmaceutical company. Thats what I wanted to do.
E.S.: You wanted to be a CEO?
P.R.: Yeah. I kept my mouth shut. I didnt discuss these political issues. I hoped to become a CEO, and do a good job as a CEO and changing some of the practices that pharma does today.
E.S.: So you saw yourself as another Hank McKinnell down the line?
P.R. Well, I thought I wouldve performed better than he did. I wouldve acted differently. But that was my objective.
You know, we all have a dream. Ive put some of those things in practice when I was running my division in Europe. I dropped prices very significantly. I doubled sales in a couple of years. I did both things good things for the business, but also something good for society. I had hoped to be able to do that on a bigger scale.
Once, when I was in the situation where Pfizer isolated me, where the drug industry stopped wanting to have me for interviews, thats when I realized that Im here, Im a vice president. This is not moving on. And if Im going to be able to have an impact, and a chance to do something, this may be my last chance. I was still employed by Pfizer. I was still a vice president. I didnt know if anybody would listen to me, but thats when I decided to speak up.
And I didnt have a significant downside to lose. Pfizer had already isolated me. I was alone in the building with my secretary and nobody else around. I had wanted to achieve change from within. But I decided this was it it was now or never. And what people didnt realize was that all interviews had stopped. So it was to take a position. Of course, that worked out much better than I thought in that people really did pay attention.
The second part of that question is about blogging, which was an extension of that, although blogging was really for fun. Its hard to get in the press. Theres so much to write about. And its easy to become a pest. Its a tough battle. A blog gets you an outlet and you can write whenever you want. Initially, it was fun just to see if I could come up with something to write about every day. Then it turned out to become a good vehicle.
Its not necessarily something thats a good thing to do, from a legal point of view, because anything you say obviously, the opposing lawyers can take it, and have taken it, to the judge to use against you. Its not necessarily something you can use to your benefit. Im guess Im the exception to that rule. Im prone to take a little more risk. And I have an agenda I want to impact things, irrespective of what happens with the litigation.
And as far as the benefits of blogging are concerned? What Im doing now is trying to do the right thing and, quite frankly, trying to survive.
You try to push different buttons. You try to do different things and hope something will come out of it. If I keep blogging, will it mean somebody will offer me a job based on something Ive written? I dont know. Maybe thatll happen. Its a long shot. Will I be able to support myself writing? I dont know. Five percent of all authors can support themselves. Thats not too many. But five percent can.
You have to have to balls up in the air and hope a few of them work out. Maybe the litigation will work out. I expect it will. I expect it will take five or seven years or 10 years. So I have to support myself until then. So I have to do all these different things. Its really a fight for survival, but in a way thats fun. Sure, you can take a job driving cab. Thats a fine job, but after having studied to become an MD, and done all these other things, you really want to use some of that knowledge. And the only way is to do exactly what Im doing right now, which has been a lot of fun. It hasnt generated that much money yet, but as I just said, I started working with a new law firm. It seems that things are starting to happen.
E.S.: You talk about having some fun and at same time, using the blog as a primary vehicle to get the message out. What do you think of criticism that the blog content is erratic and at times, havent addressed the pharmaeutical industry or its issues at all. And so youve diluted your message and created an impression you didnt want to create that youre all over the map. You had this cause, but now youre cut loose by your former employer, youre all over the place on the Huffington Post. You even had a public spat with the Huffington Post and it seemed that, instead of sticking to the issues, the passions that drove you, youve become someone whos constantly involved in sniping of some sort, and not even over issues of concern to a public that wants to read about prescription drugs.
P.R.: Thats a good point. Yes, if you work professionally at something and want to become an activist in a particular area, you should just stick to that one message. Quite frankly, my response is its a blog. Its not that serious.
E.S.: But dont you want to be taken seriously after all youve been through? You poke your head up, very unusually. To be a whistleblower anywhere is unusual. In the pharmaceutical industry, there are many whistleblower lawsuits filed, but the public doesnt really know about any of them. Its not the sort of thing that gets too much publicity. But you pushed yourself out there and stayed out there.
P.R.: The way I view the blog, which has a very extensive legal disclaimer about how to view the blog and what its all about, its like the Colbert Report on Comedy Central. Its serious but it has a lot of fun with a situation and surrounding issues. So its taking the important issues but making it entertaining.
I get bored myself. If I were just writing about whats bad with pharma, it would get really dull and nobody would read the blog. Secondly, not everything is bad with pharma. Theres a lot of good stuff there. Its an industry I supported for 20 years. I just think we should change certain things. So I just point out some of these issues. But I also write about broader issues. And Im finding my way as a writer. But I wouldnt have the readers I do if I hadnt had some fun with it and enjoyed it.
E.S.: So youre saying its a strategy. You didnt just stumble into what youve blogged about?
P.R.: Its a strategy to make it entertaining.
E.S.: Did you start out that way?
P.R.: Yeah. I tried different topics that spanned quite a bit.
E.S.: Do you ever feel that you drill so deeply into something and say to yourself: Maybe Ive gone too far? Maybe its time to go to a different topic? Maybe I appear as if I cant let go and should let go?
P.R.: No, because I have a background and special knowledge in the pharma industry, it would be strange if I didnt cover it. And point it out interesting tidbits and facts as they come up. But that doesnt mean youre harping on the same issue.
For instance, when it comes to reimportation of drugs and pricing, I havent written much about that for a long time. And quite a few people have pointed out that its pharma blog, but I dont write much about pharma. So for a couple of reasons, people may think Ive moved on, in that sense, and Ive written about things that are fun to read about.
E.S.: Where are you taking the blog now? Will it be about something other than the pharmaceutical industry?
P.R.: Im undecided. Its a blog, which means you do whatever you feel like for that particular day. Youre impacted by the readers comments and what they seem to like. Im a marketing person and Im interested in what my readers are interested in and what they care about. And so Ive used different tools where I could have the readers vote on what they wanted me to write about pharma, interesting stories about this or that. And so I have all the data, and basically, my blog very well reflects what readers have decided to see. Half the people want to see things about the drug industry and then you have a couple of other categories that were more off-topic.
E.S.: What other kind of writing do you plan to do?
P.R.: My next project, what Im really waiting for now, is some fiction writing. My first manuscript is for a fiction thriller has just been completed and Im waiting to do a conference call with my agent.
E.S.: Will the pharmaceutical industry be in there?
P.R.: Its a big-company thriller. Its set in the drug industry, because its something I know and I can bring more reality to it. And the amazing part is that, some of things I wrote that I thought were fiction, I learned later werent fiction. Like when I found out Pfizer has a high-tech security bunker with monitoring equipment, where Jeff Kindler had himself shot in a picture for Pharmaceutical Executive.
I didnt know that such a thing existed, but I used something like that quite a bit in the book. I was just surprised that reality was ahead of me. The next step is to see if we can sell the manuscript. It 100 times harder to sell a fiction manuscript, compared with non-fiction.
E.S.: How is the pharmaceutical industry portrayed?
P.R.: I think the pharmaceutical industry is portrayed realistically. It really shows the fights internally, between the companies. Its warfare what goes on. You talk about warfare when it comes to gaining market share. Between the different people internally, who try to survive, who try to get up to the highest position, its a battle. Its a daily battle.
This is fiction, a thriller. So clearly, it takes things a couple of steps further than you may see in any company, but the way people behave and interact, I really try to capture that.
E.S.: Do you think youll get pegged as somebody whos trying to beat up the industry?
P.R.: I think I was pegged as that a long time ago, which really isnt quite true.
E.S.: So, youre not the anti-pharma?
P.R.: Listen, I gave 20 years of my life to pharma. I would like to to run a pharma company. My point is that some of the guys who are running pharma are doing the wrong things from a marketing point of view, the wrong thing for society, and theyre doing the wrong thing for the industry. And thats part of the reason theyve done so poorly.
Theres a reason Hank McKinnell lost 40 percent of his stock value. I think pharma is needed and is important. My experience is theres tons of very good people in the industry.
But of course, none of these people are used to one of their own standing up and saying the emperor doesnt have any clothes. And then some of them get very upset. And things get polarized and youre cast as anti-pharma.
E.S.: Are you locked in this position where you have to be visible and vocal and critical in order to sell your blog, your books and get any sort of consulting? Assuming you cant find a position you like, which you say is unlikely.
P.R.: Well, it wouldve been wonderful if I had the book ready a year ago. I think a lot of people have written a lot about my story. So now that the book is out, I have to repeat some of it. Clearly, for an author, its important to be visible. But you and I both know that I cant just create PR and stories, because it has to be real, and really adds on to the story. So I dont think it would work if I just tried to keep up with issues. The more you try to keep people informed, the less theyll listen, because it just becomes a nuisance. Thats the art of trying to be out there.
Clearly, Pfizer has stated that, in very nasty words to the court and others, this is some kind of self-gratifying ego trip. You know, its fun to be in the newspapers the first month, its kind of nice the first year. But eventually, its not that big a deal. It definitely helps sell the book, because I cant afford to pay for an ad. And clearly, I have had it in the back of my mind, knowing the book would come out, that its important to build a brand. But that wasnt part of anything at all in the beginning, which was way before the book was developed. When you look back, it may look logical, but sometimes coincidence looks logical as well.
E.S.: When youre not busy blogging or litigating, what do you do?
P.R.: It turns out that most of the time, I am working, at least if you ask my wife. Otherwise, I play with my kids. They know if the sun is going down, theyre allowed to play with daddy.
E.S.: You live in an area where there are a lot of people who work for pharma or do business with pharma. Does it make you uncomfortable, given your high profile and criticism, to walk through town or see people you used to know? Now youre portrayed as an outsider and a sniper.
P.R.: This was never, ever a role Id dreamt of in my career. If I could have seen me five years ago, I would have been pretty shocked. At the same time, this is also about winning and proving youre right about certain things, even if it comes at a high price. Winning depends on how you define it, too. If nothing else, winning public opinion.
Theres been so much going on. Pfizer has said so many negative things, and outright lied to the press, in a very sophisticated manner, through court papers, that I dont really have that much to lose. I can be very straightforward. I can say exactly whats on my mind, because Ive been pretty beaten up in the process. So it makes it quite easy. Also, I have a pretty thick skin.
Of course, you do learn who your friends are. But if you been around awhile in life, that shouldnt be surprising either. Youve been in business for 20 years, you know how people operate and how very little sincerity there is anywhere. Its all about me, me, me, and what kind of advantage I can have in a situation. People want to know what kind of advantage they have and once thats over, they dont care about anything else. There are surprises. But I think Im pretty realistic about the whole situation.
E.S.: And when Pfizer says youre on an ego trip, what do you say to that?
P.R.: Well, you know, as far as it goes for being active with the press this year, for instance, I had a big hurdle to overcome, because when Pfizer fired me, they had planned this for a very long time, and literally, dozens of lawyers and PR people were involved. We know they tried to put out certain things that were complete lies that played well in the press and that I blackmailed them, which was completely untrue.
So it took me six months of work to get out the real story. Thats why I worked with various newspapers this year to get out the full story and showed some of the documents. To set things straight. It was a long process to do that. I wouldve like to have waited til the book was out, because it was important to get the story out. At this point, publicity is important because that sells the book, and thats the only way to support myself. And if you worked for a long time on something, you want people to read it. So it is important. Its not something you get a kick out of doing, its part of the process.
E.S.: If you had the chance to do something over, what would it be and what would you do differently?
P.R.: Ive thought that thought so many times. I wouldve gone straight to the police, the Justice Department. I would not have gone to the corporation. My experience has been, the company doesnt appreciate you coming to them. My advice to anybody thinking about something like this dont do it. Keep your mouth shut.
If youre in a situation where you have to do it, where I felt I was, then go to the authorities. Dont take your chances with the company. If I could just go back, I would have either gone straight to the authorities or gone to the company much earlier.
If I had to give advice, Id say just avoid the situation. Thats the feeling I had when I joined Pharmacia. People thought, Here we have a serial whistleblower and hes doing it again and so clearly theres something wrong with this guy, because it keeps happening. And the truth is the opposite was going on.
When I went to Pharmacia, I wanted to stay as far away as I could from anything that smelled funny. Its a no-win situation. I knew that. I had that experience. Im a vice president for a franchise where there may have been off-label distribution, which is a felony. All of a sudden, my hand was forced.
It took me a year and a half before I approached the authorities. I tried to work with the company, both Pharmacia and Pfizer. I didnt go to the authorities until I was forced and threatened to fire me and became very hostile. Of course, we all know that everything I asked for, well, Pfizer has now changed. I asked them to stop things Pharmacia had continued to do. So I feel I was right. In the end, they did what I wanted them to do. But of course, they didnt want me anymore. It didnt matter that I had good results.
E.S.: Hasnt Pfizer argued that the government declined to join the case and so in the end, maybe you werent right.
P.R.: Theyre trying to have it both ways. First, they go ahead and write these letters to the FDA and the Justice Department saying theres a big problem. Then they try to say the government doesnt want to intervene, so theres no problem. Theres an ongoing grand-jury investigation, criminal investigation and if there was no problem, this wouldnt happen.
Normally, when the feds call a grand jury in 98 percent of the cases, they indict somebody, because they dont waste all that time for a year or a year and a half. So we are very far from the end of the story. Pfizer is trying to spin things different ways.
The Justice Department is completely overworked they only take 10 to 20 percent of the cases that are filed under qui tam False Claims Act in Boston, because they have so many cases.
They know the government has put it in rules to make it more favorable for a private attorney to pursue a case. Marketing 101 is blame the whistleblower. Number two is make him out to be crazy. And it just goes to show its a dishonest corporation. If it wasnt, they wouldve had to sign two corporate integrity agreements.
E.S.: But they havent signed one involving your charges.
P.R.: Not yet. These investigations take several years.
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