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Pfizer and Nigerian Officials Both Charged
Most people here will know the wider background of the Trovan case as well as the fact that a recent ruling allows the Nigerian plaintiffs (or their survivors) to file suit in the United States. What had been less clear to me is that the charges brought concern both illicit behavior by Pfizer as well as complicity by some number of Nigerian officials.
I do not know whether it was alleged they were "on the take," but earlier studies suggest that pharma ranks number one in bribery used overseas. Braithewaite (1984) - certainly no radical - writes that "the pharmaceutical industry has a worse record of international bribery and corruption than any other industry." That may well be because that is the "way of doing business" in a number of such venues, as well as because of the sheer number of overseas clinical trials in which such a way would be relevant.
A colleague of mine who is an M.D., Ph.D. in pediatric infectious disease and director of IRBs at my university sent me a copy of the recent appelate court decision. The link is below.
http://www.ca2.uscourts.gov:8080/isysnative/RDpcT3BpbnNcT1BOXDA1LTQ4NjMtY3Zfb3BuLnBkZg==/05-4863-cv_opn.pdf
In a recent thread the distinction was made between issues that concern industry insiders and those that concern patients. If an issue like this does not concern both groups - which, in reality, are the same - we are in deeper trouble than I thought.
Friday, February 6, 2009
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This case is very interesting and yet it is very difficult to know exactly what happened.
ReplyDeletePfizer always maintains that they have been very involved in Nigeria for the last 50 years. I think many of us here will agree that the way business is done over here is not the way we do it over here, although, the lines are becoming blurry at this point, in the wake of certain scandals over here...
Before Trovan was used in Nigeria, Pfizer maintains that it was used on about 5,000 American children.
The results of the trial did show that Trovan saved lives, but it also showed that the comparator drug at the time, Ceftriaxone - Hoffman La Roche, was very efficacious as well and in fact, the doses of Ceftriaxone could be significantly reduced and still be quite efficacious, and this was important with regards to reducing pain caused from intramuscular injection of the drug.
In fact this was confirmed in an independent study conducted by Doctors without Borders in 2003 with Ceftriaxone. Therefore, it seems to me if I understand this right, that Pfizer is claiming that while their drug Trovan was efficacious, the clinical trial also showed that the comparator drug, Ceftriaxone, was similarly efficacious.
Pfizer also maintains in various media statements that it followed all the rules and ethical obligations to the letter of the law to satisfy the Nigerian government.
My big concern here is we are constantly demanding that big pharma get their drugs into the the under developed places of the world.
But how can this be done when government infrastructure in many of those countries is lacking. This gets us all into big trouble.
What about the WHO (World Health Organization)? Should all of these trials be cleared by them so that we all feel that there are no conflicts of interest?
Are we asking Pharma to be missionaries, diplomats, etc. This is clearly not their core competency.
Yet, going through governmental agencies can bog down the process and in this case, more children would have died. There has to be an international ethical panel that helps fast track these issues and helps us all to ascertain that obvious conflicts of interests are being addressed before and not exposed after.
Interesting stuff, Former. As you know, the plaintiffs charge Pfizer used an _unduly_ low dose of ceph in order to make Trovan look better. Of course, I have know idea where the truth lies.
ReplyDeleteRe: infrastructure support, Phil Hilts and others argue that experiece with AIDS drugs shows that, in many countries, the assumption of problems has not been borne out (as often as we hear it repeated). There, too, I only go by what I read!