Pfizer Settles Trovan Lawsuits

Here at Two Decades & Counting we've been following the legal battles over the Trovan investigations in Nigeria in 1996.  You can review the case and its ramifications in the US legal system here, here, here, and here.  Today Pfizer announced they had settled "lawsuits stemming from" the case for undisclosed sums, with deleterious effects on Pfizer's stock price.

WikiLeaks and Trovan

If you thought the WikiLeaks story had nothing for you, think again.  Today's New York Times discusses a State Department cable, made available via recent the WikiLeaks dump, alleging Pfizer's attempt to disrupt the Nigerian lawsuit following several deaths after the experimental use of Trovan in Kano in 1996.  According to the Times story, the State department accused Pfizer of hiring investigators " 'to uncover corruption links' to Nigeria’s former attorney general and apply pressure to drop lawsuits against the company."  Nigeria's former attorney general, Michael K. Aondoakaa, was quoted in the piece saying he knew nothing of any Pfizer attempt to investigate him. Pfizer denied the allegations as "simply preposterous".  This is just the latest in the continuing saga of Trovan in Nigeria, which we have talked about here and here.

Big Pharma Wants to Buy You Lunch

Jessica Wapner of Slate explains how the pendulum may have swung a bit too far in this piece on the value of industry sponsored medical education, here.

The latest in the Pfizer/Trovan saga comes down from the US Supreme Court today.  The Supremes have kicked the entire mess back to the lower courts by ruling today that it won't stop Nigerians from suing Pfizer in the US.  Technically they didn't rule so much as declined to hear Pfizer's appeal of the lower court ruling from last summer.  We have run down this story a couple of times on this blog, here and here.  Pharmalot's take is here.

Pfizer, Drug Pricing, Conflict of Interest

The photo was taken last December in New Dehli.

Lately this blog has been beating up on Pfizer, here and here. They are big, they can take it. Here is some more. Fierce Pharma today links to a Telegraph report covering Pfizer CEO Jeffrey Kindler's rehabilitation tour, first last week in the UK and now in the US. This year Pfizer has not once but twice made huge court settlements: one for the Trovan case discussed previously, and the other for $2.3 Bn to settle the ongoing investigation of its off-label marketing practices, the largest settlement of its kind, in the same month that Lilly settled its Zyprexa woes for $1.4 Bn. Like those television preachers who, after getting caught with their hands in the till - or worse, quickly come back on stage with a tearful repentance speech and then start lecturing everybody on how they should behave, now we have the spectacle of one of the largest drug companies telling us all that we should follow the rules - or else.

And it is the 'or else' that matters here. We don't need to spend much time adjusting our expectations of Pfizer or its kind. Kindler makes clear in his remarks the real motivation behind all this soul-searching: change or face increased regulation. Kindler is not the only one worried about this. Merck's chief exec was on the stump about this very same issue last spring. At least he is on to something that would actually improve big pharma's image as well as improving people lives, and that is pricing. Drugs cost too much in this country, even after factoring in the high development costs and low ROI. Nearly every other major government and quite a few minor ones control drug prices, but not the US. People on fixed incomes have to decide whether they are going to buy their medicines or pay the heating bill. That should not be. Apparently Congress thinks so too, but do they think so enough to do something about it?

The Pharmalot blog seems to have relevant content a lot of the time. Today they link to a new report out from Seton Hall University on managing conflict of interest in clinical trials. Some of the report's suggestions seem unwieldy, such as not allowing payment for screening activities - who will bear those costs if not the sponsor? And what incentive will investigators have to find patients for trials, a task that has become increasingly difficult in this country? If you go to this link, be sure to note the comments section at the bottom.

And if you've made it this far, how about a little shameless self-promotion? I will be presenting at this meeting Partnerships in Clinical Trials in Orlando, April 2010. Hope to see you there!

Fall Term Catchup

The picture is of the Capitola, California beach on a beautiful fall day last week, the last warm day before temperatures dropped. The fall term is nearly over (yay) and my inbox is stuffed with items I've been marking to blog but somehow never found the time. So here is a whole bunch of them in one go.

First up: a nice piece on direct-to-consumer advertising from Slate. My students know I love to take off on big pharma's fatal attraction for DTC advertising and how it can be directly linked to the problems of Merck's Vioxx. While the Slate writer makes a nice, facile point with his analogy of running shoe ads, there is still a fine line between educating and developing the marketplace versus creating one out of whole cloth.

This piece from MicroArray blog points out an issue that I see within the scope of Anhvita, and that is the propensity of trained monitoring staff within India to 'job jump'. This is creating a work force with great breadth but insufficient depth, and is also contributing to a loss of continuity for sponsors which could directly and adversely effect safety reporting, among other things. We need to create a cultural shift that encourages professional staff to develop all their skills, instead of leaping to the next attractive salary and perks package.

Here is an update to an item I posted a while back about the Pfizer-Trovan-Nigeria case. In case you thought justice was imminent after the US 2nd Circuit Court of Appeals' decision last summer to let the case finally be heard in the US courts and Pfizer's subsequent $75M settlement - think again. Pfizer did indeed fund the settlement, all but $30M of which is going to line lawyers' and Nigerian government officials' pockets, but they also appealed the decision to the Supreme Court. The Supremes have asked the Obama Justice department to render its legal opinion, so we may see a ruling this term. Meanwhile, Pfizer is continuing its one-company crusade to lose the hearts and minds of the prescription-buying public - who is not inclined to cut the pharma industry a break in the best of times - by requiring victims in the case to submit DNA in order to receive compensation. It's all here. One of the salient facts of the case is that there were no medical records left behind from the two week study conducted at Kano in 1996, so it isn't immediately clear exactly what the DNA samples are supposed to be compared to. If the whole thing is not a ploy to avoid paying out compensation to the victims, then Pfizer certainly seems comfortable with giving that very impression.

And speaking of fall days, this one is over. More next time.