Will Glaxo Sue Steve Nissen For $15 Billion?
18 CommentsBy Ed Silverman // June 6th, 2007 // 2:34 pm
Why not? After all, the drugmaker threatened to sue John Buse or his employer, the University of North Carolina, for $4 billion because the endrocrinologist discussed the potential risk of heart attacks with Avandia at an American Diabetes Association meeting in 2000. After he did, SmithKline Beecham’s stock tanked (Glaxo later bought SmithKline).
Tachi Yamada, who now works at The Bill & Melinda Gates Foundation (that’s him in the photo), called the chairman of Buse’s department - who was his boss -and complained about data Buse compiled to review the issue. Buse told a congressional committee earlier today that he was called a “liar” and that the threat of a $4 billion lawsuit was mentioned twice.
So now that Steve Nissen of the Cleveland Clinic Foundation has single-handedly caused about $15 billion of Glaxo’s market cap to evaporate, shouldn’t the drugmaker threaten to wipe out his retirement savings? Or go after the deep pockets of his employer, which dominates a good chunk of Ohio’s health care apparatus?
Has anything really changed in seven years? Glaxo insists it has. The drugmaker issued a statment saying: “We regret if, at any time, Dr. Buse felt the conduct of any GSK employee was contrary to the spirit of open, scientific debate.” Hardly an apology. And hardly an excuse for threatening a lawsuit against someone who attempts to have an open, scientific debate.
In his own testimony today, Glaxo’s R&D chief Monsef Slaoui, excused away the behavior by saying the intimiation was the work of a “passionate” scientist, who used to be his boss.
The lesson? Watch what you say or a drugmaker, or at least Glaxo, will threaten a lawsuit. Unless, of course, you first go to Congress with your info. In that case, Nissen is unlikely to be served. But not every doc with a conscious has his profile or clout. Even if the episode was seven years ago, it has to send a chill down the spine of ethical docs everywhere.
Dr. Remulac
No company should employ strong-arm tactics, extortion, threats, etc in dealing with anyone on a scientific level. Likewise, a scientist must be responsible, frame data in the appropriate light, and equally understand the dangers of over- and under-interpreting data. Frankly, what Buse and now Nissen did, IMHO, is raise alarmist points without properly framing them as being inconclusive. At some point, you have to be brave enough to simply say that this is a matter of my opinion or conjecture, and that the available data suggest that there is a possibility, but not clear proof, of X. In a way, it’s a little like yelling “fire” in crowded theater, when all you’ve seen is someone light their cigar. Nissen and NEJM knew full-well that there would be a firestorm over this, and though they cannot be responsible for what the lay press does with this info, they are responsible for helping frame a reasoned debate in the aftermath. Nissen craves the spotlight (which further helps his employer, and to attract more grant dollars for future studies), and NEJM likes the free advertisements.
John Mack
I think Nissen did “frame his data in the appropriate light.” At least that is what I heard him say at the Congressional hearing today under oath.
It’s about time that critics — and I mean everyone on both sides — actually listen to what people actually say rather than depend upon what their favorite pundits say or what the press says.
Maybe I shouldn’t take Nissen at his word, but he did encourage people to actually read what he said in his article, which is easy enough for anyone to do should they wish to.
Lisa Van Syckel
Hasnt Glaxo and others complained about greedy Plaintiff Attornys, and Frivilous Lawsuits…..
Dr. Remulac
I disagree that Nissen framed his arguments appropriately. He left out of the paper the fact that the actual overall % rate of MI was ~0.6% and CV death ~0.4%, as well as that the absolute differences between the Avandia and reference groups was only 0.021% for MI and 0.136% for CV death. Instead, he and the NEJM, chose to report only the more sensationalistic “relative” risk values of 43% and 64% for MI and CV death, respectively. When absolute risk is so low, even very small differences can have exaggerated meaning on a realtive basis.
Dr. Remulac
To Lisa - GSK won’t sue, but don’t rule out a lawsuit by shareholders. There’s always a lawyer somewhere happy to take up a lawsuit, no matter how frivolous!
Lisa Van Syckel
GSK knew of, the off-label use of Paxil, knowing full well,that this drug, was maiming and killing America’s children…I wouldnt put anything past them..
Lisa Van Syckel
That last post was for Dr. R…
Hank
I raised the question on the “sister” thread of how common people feel the threat of suits, and similar kinds of manipulation may be. We hear about them when they impact “name” researchers (like Singh in the Vioxx case), and, of course, those are the KOLs that cos. most care about. But I wonder how many less established researchers have been “subdued” by these or similar tactics, or simply the echo of them, via their deans, seniors, etc.
Needless to say, “relative risk” is also relative - to how many people are taking the drug, etc.. Once one has statistical signicance, p=.03 in this instance, it’s potentially very serious business, as everyone seems to agree. At the same time, I agree that “the public” doesn’t normally know the difference - whether it’s a claimed risk or a claimed benefit. There would be many fewer statins being sold for primary prevention if people knew the absolute benefit/NNTs, particularly for women and those over 65 without significant risk factors
Dr. Remulac
Lisa - Believe it or not, I am on your side, and I have no doubt that senior management in many a pharma company has behaved unethically or even illegally in the past, and will do so again. I believe that companies themselves are not evil, but sometimes the greedy egomaniacs at the top are. Those people should pay, but not the many innocent and moral/ethical people that are still found today in all pharma companies. I gather you’ve suffered personal loss that may very well indeed be due to the actions of some of the types of people I am talking about, and for that I am sincerely sorry. I hope you find closure and peace and maybe pin a few butts to the wall as you do!
Lisa Van Syckel
No Dr. R.,
My daughter was one of the lucky ones,she survived….
Many other Parents weren’t so lucky..
Lisa Van Syckel
Dr. R,
Im sure GSK will admit privately,that I have been a real THORN in their side…………
jason
Lisa, I notice you are taking the original information as gospel. Full disclosure — I am not in any way connected to this company or any company with a SSRI, so I am not as up to date as I should be! That being said, I know I saw a huge meta-analysis on SSRI in the last 2 months that confirmed they did not cost lives. Yes, some who are put on SSRI’s commit suicide, but many who are not treated medically commit suicide. Maybe someone out there is more familiar with the study, but the bottom line was — there are risks, but the benefits likely outweigh the risks.
In the age when pharma and medical advances have hit new highs, I don’t understand why everyone wants to take a step backward. Keep in mind, there is no way aspirin would be approved today with its tedency to cause GI bleeds.
I hope if nothing else, I hope the general public begins to realize that medications are not the magic bullet for all medical conditions. If seems diet and exercise might be a better option for diabetics than carrying around the bong or taking Avandia
Dr. Remulac
Lisa - I just bet you are!! Go get ‘em!
Lisa Van Syckel
Jason,
That meta analasys you refer to was “TEENY TINY!!” SSRI’s Cause suicide in children.You would have known that had you read the Editorial of Dr. Pfeffer-(Para.6,last 2 sentences)Secondly,there is no efficay of SSRI’s in the treatment of depression in Teens(Check out Energy an Commerce,O and I).Read the staements of FDA and Pharma that were given under oath.
Heck better yet,check out Ed’s coverage here on Pharmalot and articles he wrote for the NJ Starledger.
And yes the original information is GOSPEL!! The watered down warnings will COST CHILDREN THEIR LIVES!!
Dr. Remulac
The entire field of psychiatry is bizarre to begin with. It is by far the worst when it comes to off-label prescribing (once a psych drug becomes available, they all start prescribing it for nearly everything experimentally), and also off-label promotion. I totally agree that the SSRIs as well as all the atypical antipsychotics are horribly over- and inappropriately prescribed. Both the healthcare practitioners and the pharma companies need to be spanked on this one!
Jason
Lisa, I understand your personal viewpoint. But these are troubled children to begin with. I certainly agree it needs more study and research, which is hard to do in children — especially potentially suicidal children. I don’t think the answer is to quit trying to find an answer. I have seen too many people helped by medications. With the amount of publicity this has generated, WHO IN THEIR RIGHT MIND WOULD TRY TO HELP THIS GROUP OF PATIENTS! You might as well set yourself up for the lawsuits. You could be right, but this will stop progress. If I were a pharma company, I wouldn’t try to innovate at this point at all. The risks are much too big. It seems like we are satisfied with the current state of medical care - which is sad. There are still diseases to treat and patients to help.
Hank
There was an interesting survey a year or so ago, I have lost track of which organization did it, of pharma senior managers. A striking finding was that some 40% of _them_ believed that pharma senior managers cut ethical corners for profits. An even larger percentage agreed that off-label promotion was more common than otherwise.
Of course, for this to be meaningful, you’d have to compare it with how senior people in other fields rate their cohort. There was no such comparison.
My own view is that, overall, the pharm industry attracts a _more_ ethically principled group of people than other fields. I mean, of course, the chemists, pharmacologists, and a very wide range of others who go into the field because of their wish to do something enormously useful and meaningful.
Those are not the folks to be concerned about, just as at the FDA the line reviewers are, virtually without exception, extraordinarily dedicated, excellent professionals.
Brenda
Interesting article. An associate of mine is actually hosting a forum on medical ethics in San Francisco this November, highlighting the Avandia/FDA debate. I’m curious to find out if there is any progress to be made in light of this article.