Merck, Vioxx & Cox In Paradise: Tom Nesi Explains
12 CommentsBy Ed Silverman // September 16th, 2008 // 12:44 pm
By now, the Vioxx saga is well known, and still contentious. A big drugmaker scrambles to develop and promote a blockbuster painkiller that is, ultimately, withdrawn over heart attacks and strokes. Lawsuits, recriminations and scandal ensue. Lives are damaged. Careers are threatened. Money continues to change hands. Now, though, a book has arrived that tells the tale, although ‘Poison Pills’ is written by a public relations consultant - Tom Nesi, a former exec at Bristol-Myers Squibb - not a journalist. Nesi, who relied on court documents and, for awhile, was an expert witness for plaintiffs’ lawyers, expresses outrage at Merck’s behavior. This is an excerpt from our chat…
Pharmalot: Why would you want to write such a book?
Nesi: Actually, the project took me on. It was really an accident. I had not been following Vioxx or Merck that closely. They had been a client many years ago, but I was stunned when they took their biggest-selling drug off the market. My initial reaction was it was some kind of freakish event. I didn’t think there could have been much behind it. I’ve seen things like that before happpen in clinical trials – side effects show up and drugs get taken off the market. Anybody who’s worked in a pharma company has seen failures in trials knows it’s part of the businesss. But to see a failure after $20 billion in sales is really quite extraordinary.
Pharmalot: But you’re a PR guy. Why take that step?
Nesi: I started reading some of the memos that were coming out in the media and things were being leaked online. Eventually I got more and more curious and got in contact with a law firm in Philadelphia, which actually called me first. I thought it woud be just nonsense, but once I started reading documents, it was like a thriller. I was up til 3 or 4 in the morning reading. And I realized it was a much bigger story than anybody could believe. But one of my motivations was concern that people thought this was the way the pharmaceutical industry does business and so one reason I wrote this was to say ‘No, it’s not the way things are done.’
Pharmalot: As a PR professional, what did you find about the Vioxx story that was so difficult to take?
Nesi: Specifically? That they sent one of their senior vice presidents to initimidate professors. I’m referring to James Fries, a professor at Stanford. It was a pretty well-known part of the story back in 2005, when there were hearings in Washington. But to me, something like that was unheard of. It just wouldn’t have happened at when I was at Squibb. This was not the way things were done.
Pharmalot: But how do you really know it was the exception and not the rule?
Nesi: I work inside the industry. I’ve been a consultant to many of the largest companies. My friends are in the industry. I’m not an outsider. I sat as a pr director at one of the largest drug companies in the world. And I talk to my friends all the time. We had a standard of doing business. I never heard of anything coming close to people intimidating professors.
You know, I called the book ‘Poison Pills,’ because the word for pill comes from the Greek word pharmicon, and the Greeks regarded medicine as either poison or cure. Medicine and cures can induce a form of madness, and the more I read about Vioxx, it seemed like madness. There was denial and self-perpetuating behavior. By and large, it seemed like something that swept through the company, a kind of desperation.
Pharmalot: Not to disparage the industry, but there have been other scandals.
Nesi: I wrote this as a mystery almost, because I was intrigued by what happened. And I used historical anecdotes because chicanery has been part and parcel of the pharmaceutical inudstry since whenever. So no, it’s not really new. But what sets the Vioxx story apart, or makes it unique, was the scope. Yes, it’s happened before that we’ve seen chicanery, but the level of the characters, the stars, the advertising – Dorothy Hamill. There were billions of dollars spent on marketing, the doctors involved, the samples handed out. And this was not just an action by Merck. There was total failure – the FDA, the New England Journal of Medicine, opinion leaders. It went on and on, and infected everything.
Pharmalot: What do you say to folks who would assume you have a bias, since you were an expert witness for the lawyers who sued Merck?
Nesi: I simply reads the documents and reacted. The book is the most vetted book you can possibly imagine. I was practially cross examined by the legal team at St. Martin’s Press. Did that mean I didn’t develop an opinion along the way> No. But I called it as I saw it. I didn’t become an expert witness first, by the way. I became an expert witness after I read the documents.
Pharmalot: Did you attempt to interview anyone at Merck?
Nesi: Very early on, I was told very clearly that nobody was going to comment during the litigation so I had to rely on people who were connected with Merck.
Pharmalot: What was the most eggregious action or behavior you came across?
Nesi: The most eggregious thing I saw was the reaction by the company once they saw the results of the Vigor study, which was the first to see whether Vioxx actually caused fewer reactions in the stomach. Merck knew full there were many times more heart attacks in the Vioxx group versus the naproxen group. This was a completely unique theory (that naproxen may have done a better job of protecting the heart than Vioxx). There was no proof that naproxen was cardioprotective, and they issued a press release reaffirming the cardiovascular safety of Vioxx anyway. And those press releases were cleared by regulatory and legal. This was not an isolated pr experience. One of the mysteries that still kinds of remains is who did approve those releases and whether it came from the top. The whole effort to position the drug was a companywide strategy.
Pharmalot: Who would you blame? The public relations people?
Nesi: Absolutely, I would blame the public relations people. When I started writing this, I asked myself what I would have done. Would I have given up my job? I have to say yes. I would have quit. You have to look into your own soul. I did have situations at Squibb and I’d come home to say to my wife that I’m not comfortable with the company’s positions on a drug or the way a press release was going. Every now and then, I would have discussions about far I would go.
Compare it to Vytorin, where something similar is going on. And doctors are still prescribing drugs that don’t have sound science behind them. We have to go back to the first tenet of medicine – do no harm. The pharmaceutical company is the only entity that has all the data. Doctors simly don’t know what a drug does. The company has animal and toxcity studies and distills thousands of pages for the FDA. An FDA isn’t an independent testing organization. It takes what drug company gives them.
The similarities between Vioxx and Vytorin are very frightening - and the fact that the FDA will have to take six months, at least, to evaluate the data is absurd. That is the amount of time it takes to get a fast track approval. Why isn’t the agency calling an emergency meeting as we speak?
Pharmalot: So in your view, what’s the lesson here?
Nesi: Don’t rush to take a new drug. See a new drug advertised on TV by an athlete or whoever says it’s the greatest thing, wait. There’s no such thing as a free sample – they’re the most expensive thing you can possibly buy. It’ll cost you $3 when you need a refill, not 10 cents for an aspirin or a generic. You don’t want to be the first person to take a drug and you don’t want to be the last.
And you can’t go by what authorities say – NEJM corrected no less than two articles they published about Vioxx. If I were a doctor looking for a solution, I’d look at the FDA briefing book.
There are, of course, many important issues, but the humor of the FDA, Merck, Pfizer, opinion leaders cavorting in Hawaii with Cox-in-paradise T-shirts is too good to resist. (Vioxx and Pfizer’s Celebrex are Cox-2 inhibitor drugs). A Pfizer rep who was working on Viagra said to me: “Well, we put lots of cox in paradise.”
A.
I appreciate the article and interview, and look forward to reading the book. But, as a former Vioxx user, and current plaintiff, I am familiar with much of the article’s content. For the sake of readers who may not know some of the details, please go in and copy-edit the online article. There seems to be some missing info, noticeably in the paragraph about Mercks claim that naproxen had cardio-protective properties. Thank you.
Anne
When is this kind gentleman, or his best friend, going to write the book about Lilly’s “blockbuster” Zyprexa. I don’t know the comparison between total deaths, but I do know that approximately 30,000 people or their next of kin sued Lilly and 45,000 or next of kin sued for Vioxx. I know the story pretty well because the drug, Zyprexa, killed my son and the sons of many that I know. Most were in their twenties or thirties, and all had no warning.
Salmon
I have no reason to doubt that Mr. Nesi would be surprised that someone was sent “to initimidate professors”. At one time this may have been unheard of, however I no longer believe that this is a rare exception.
It also occurred with Glaxo and Avandia. Plus during the past 9 years look what’s occurred at FDA with David Graham, Bob Misben, Leo Lutwak, Rosemary Liang, David Ross, John Gueriguian, and Victoria Hampshire (that’s ~ 5 of maybe 1000, at least those are the ones that are public). Plus I’ve seen it myself with tenured professors losing their jobs and it’s common with junior people being denied tenure or even jobs. This may have been unheard of at one time but during the past ten years it’s become standard operating procedure.
As a friend of mine who’s a VP of clinical research at a major pharma company says, “you don’t call the baby ugly”. If anyone including the originator of the original safety information who is supposed to notify management does anything more than just that and anyone who doesn’t go along with upper management is then simply gone.
Salmon
Lipid Researcher
I believe that Mr. Nesi is absolutely correct that the next one with be Vytorin, and along with it Zetia. It appears that the biggest culprit here will be Schering-Plough. To me, they look like the company without a conscience, doing whatever it takes to make money, money and more money. At this point, Big Pharma is disgusting. Of course, they have a lot of company in the rest of corporate America. We’ve lost our moral compass.
Justice in MI
On the issue of intimidating researchers (when it clear is that), this is one of those delinquencies that is entirely outside the purview of FDA. So is bribing, or attempting to bribe, people _not_ to do studies, some cases of which I have personal knowledge. This is also, of course, entirely outside the purview of FDA.
This is one of several reasons whey, even if we had a utopian FDA (wistful thinking), civil liability would still be needed. Actions of this kind are simply not covered by what FDA does, but they are relevant in both criminal prosecution and civil actions.
Ger
Ed, this type of story is what distinguishes Pharmalot from others. Fresh and informative. Well done.
RVN
There were about 50,000 plaintiffs in the Vioxx settlement. Merck agreed to pay nearly 5 BILLION dollars to those plaintiffs. The largest product settlement in history. It reflects well for a company to not only admit fault, but to accept responsibility, and to offer compensation. Of course, no dollar amount will bring back a lost loved one, nor heal the physical damage done, just as automobile insurance will not replace someone lost in a collision. But they are offering a measure of compensation rather than forcing the victims into years (perhaps decades) of litigation for an uncertain outcome. Merck should be thanked for setting a precedent on compensating victims, which will be used by corporations for years to come.
Researcher101
I agree with Anne regarding Zyprexa. I’ve reviewed many of the court documents and Lilly appears to have put its own financial interests well ahead of concerns for patient safety.
On another front there is the issue of Vytorin: there are suggestions that statins may have their beneficial clinical effects not through lowering cholesterol but through an anti-inflammatory mechanism. This might explain why lowering cholesterol with Zetia (the non-statin part of Vytorin) may have no benefit. If this turns out to be true, I wonder how long it will take for this to be accepted in the medical community? There are so many vested interests in this case (doctors, health advisory boards, diet advisors, food companies, etc.), in addition to the drug companies. The cynical side of me suspects that, if cholesterol levels are clinically irrelevant, a shift in opinion will not begin until patents on all of the statins expire.
southern Girl
the not so funny thing is after being on Vioxx, having a heart attack, my doctor prescribed Vytorin for cholesteroland to prevent a second MI… I can’t win .
csmith
Merck DID NOT admit fault and accept responsibility. They are not doing this settlement to offer compensation. They are doing it because they know they are guilty and trying to get their a**es out of more hot water.
bbh - dh
…. Unfortunately in the case of the vioxx settlement The Honorable Eldon E. Fallon, United States District Court, Eastern District of Louisiana, has not done an adequate job assuring a balanced, or even reasonable, playing field for all concerned. His actions seem more intent on protecting Merck and clearing his docket than ensuring the legal rights of the litigants are upheld.
The federal and state courts have been overwhelmed with all sorts of Mass Tort Litigation far too long. I believe the Merck Settlement Agreement, had it been executed properly, could have been a model for Federal Legislation, which would reduce the high cost of the plaintiffs’ and corporations fighting each other. I certainly DO NOT believe the Merck Settlement Agreement as it stands could be a model for Federal Legislation. Judge Fallon did not provide a “level playing field” and allowed the parties to proceed in a non-transparent (“secret”) manner. He has NOT engaged to protect the legal rights of the litigants, whose lawyers, for the large majority, have not been encouraged to provide proper representation. These lawyers appear to have been “brow beaten” into recommending a settlement that seems to not even represent 10% of an “average” litigant’s damage, all in the name of clearing the dockets and “getting something in this lifetime out of Merck” rather than providing true justice. Many have expressed concern, and remain perplexed, as to how Judge Fallon could provide proper judicial oversight while at the same time being Merck’s “administrator” – it just does not make sense.
I am a member of group called “Vioxx Plaintiffs’ Education Group or VPEG”. VPEG was born out of Vioxx victims wishing to share information and to try to understand the details of the settlement which were not being met by other means, including the litigant’s attorneys. Members also discuss the damage Vioxx did to them and their families and to help support and educate each other.
bbh - dh
Some pieces of a couple of recent POSTS with an observation that the Merck Vioxx MSA MAY be headed towards Congress…..
… a theory was advanced that should it have merit, frankly makes my stomach sick … It is one that the MSA (the agreement) was actually written so that it could then be transferred into LAW by Congress (or say most of it…) so pharma and other industry will use it to shield themselves from MASS TORTS.
That does not mean that locally one cannot sue for being run over by a car, but it WOULD mean that damage perpetuated by a drug company will have one heck of a hard time gaining any shred of adequate compensation for the rest of our lives, and our children’s also. It would certainly seem to encourage adequate testing to come out of the laboratory and into the public, and will discourage proper pharma post-marketing tracking/analysis. It will make litigation merely a fixed, product life cycle cost. By providing fixed costs and capping risk, it will then permit other reckless and too risky behavior by the pharma industry. The ramifications get worse…. unless MAJOR NOISE IS MADE to the public, the Attorney Generals, the US Supreme Court, and the best we can do to warn Congress. It will complete the “loop” and it all fits very well. I am not a radical – in fact I have quite conservative values in re to family and right/wrong – but in re to CIVIL RIGHTS of MANY kinds, I would consider myself in the liberal camp, as I DO see movement towards as I say – “peeling away our CIVIL RIGHTS like onions”.
Shall it have merit, it is one of the worst things that we have seen in our lifetimes in re to real perversion of our Legal System; with Pharma/the courts and the large firms largely in control of protecting pharma, and now looking to suggest to Congress – “we have the perfect solution – look, it’s already done… all you need to do is sign on the dotted line, and you can go tell your constituents how well you FOUGHT for TORT REFORM (actually is DEFORM) - but the PUBLIC does not, cannot yet currently differentiate between frivolous litigation (and of course we understand that) and the massive fraud and collusion taking place under the guise of “TORT REFORM”.
IF you are a vIOXX Plaintiff and wish to get involved, in addition to learning/educating/sharing – please feel free to apply:
http://groups.yahoo.com/group/MerckSettlement/
Posted by Dennis Harrison (bones)
Sunday, November 09, 2008 1:42 AM EST
What I get out of CAFA is that jurisdiction for large class action is moved to Federal; that would then seem to be the first stage as it consolidates POWER centralized. Note that the STATES, by the way, ARE AGAINST PRE-EMPTION; kind of tells you that the STATES continue to be very way of Federal Power over-reaching. Some things certainly make sense from a Federal Point of view, certainly that is the case. However, in the case of TORT/PHARMA - it seems clear to me that the first step is to centralize power into the Federal Government, where it then becomes under their control how to move further.
http://en.wikipedia.org/wiki/Class_Action_Fairness_Act_of_2005
Then, along comes TORT REFORM - and since the PUBLIC DOES not understand what it really means, the PUBLIC thinks hot coffee/and near $50M (amt ?) award. SURE, the public opinion says, something must be done, let’s support TORT REFORM.
http://en.wikipedia.org/wiki/Tort_reform
OK, now along comes PHARMA. Things are starting to look great for Pharma.
TORT REFORM? what a great way to PUSH a private “settlement” (DEAL), surely the public at large will support such a brave effort…
OK, now we get the “settlement” (DEAL)….
The Public has been quoted with MANY mean spirited quotations (we are blood sucking thieves, we steal $ from the research for children, we steal $ from greater research efforts, etc…).
Merck poor mouths itself and declares that $5B is SUCH A LARGE amount (don’t we know where that amount gets now a days divided by so many people?).
The COURTS say - sure, we have been instructed by our Congress and House to seek TORT REFORM;
The COURTS collude (sorry, I know a lot don’t like that word…) with PHARMA and design/collude the referred “private settlement” (DEAL) that has, without question, stolen CIVIL RIGHTS up the kazoo….
BUT, then go further…. while at it… why not actually draft the MSA (”settlement” (DEAL)) so that we can then bring it to the legislative body for their signature? Sounds quick and easy enough…
And that is where it seems to be:
1 - pharma knew for a long time where this was going…
2 - the courts are only too glad to have a nice, easy way to wipe away their dockets…
3 - the legislative branch wishes (this is NOT an issue of which party) to look good to their consitutents and claim - SURE, we have WORKED VERY HARD AT TORT REFORM (i.e. signing what Merck DIRECTED for the entire industry)…. By the way, they do so via illegal “bill of attainer”
http://en.wikipedia.org/wiki/Bill_of_attainder
Besides seeking JUSTICE AND FAIR COMPENSATION, a goal of 2009 needs to beat back this new realization.