Pradaxa: a bid for enrichment

Vincent J. Curtis

15 Feb 14

The report below is in respect to a law suit in which a university located in my hometown is indirectly involved.  The case involves excessive bleeding caused by the use of Pradaxa, a drug said to be superior to warfarin in the control of blood clotting due to irregular heartbeat.  The blood clotting from inrregular heart beat can break free from the heart, travel to the small blood vessels of the brain, and cause a stroke.  Warfarin, pradaxa and other drugs prevent clots from forming to begin with.  This condition has dangers of its own.


I read the excellent report Steve Buist, Investigations Editor of my local newspaper, on the Pradaxa case, presently ongoing in East St. Louis.  Based on what he wrote, there seems to be one or more logically fallacies at the heart of the court case.  The most obvious one may be boiled down to the distinction between the relative and the absolute.

The PHRI study, by which the FDA approved Pradaxa, compared the relative effects of warfarin and two dose levels of Pradaxa.  Among the three, the 150 mg dose of Pradaxa was relatively the best for treating blood coagulation problems.  But that result does not establish that, absolutely, there will be no complications in using the the drug at that concentration.  The case against Boerhringer Ingelheim and PHRI seems to be based upon the belief that Pradaxa was held up to be absolutely safe, when in fact the clinical trials only showed that it was relatively the best treatment among those studied. Moreover, these results are statistical and based upon probabilities; they may not hold in individual cases.

I am a little surprised that the PHRI study did not include a control group of sufferers who were denied any kind of treatment.  A study that included that kind of control group would presumably show that, absolutely, treatment with Pradaxa provided the best of outcomes, again statistically. It would also show that none of the outcomes were as good as perfect health.  These people are suffering a morbidity, after all.  The taking of Pradaxa is to substitute a less bad morbidity for one that is worse.

Thus when people who are being treated with Pradaxa suddenly suffer abnormal bleeding, against what are we to compare that abnormality: relative to a warfarin treatment?  What of the absence of treatment altogether?   Would the patient have suffered a stroke instead of bleeding in that time period?  In individual cases, no one can say what the absolute outcome is going to be.  We know what the statistical average should be in a large number of cases.  We know what we would like it to be in individual cases: to be like the restoration of perfect health; but that ideal is not always possible. And grown people ought to know that.

In addition, when one studies a group of 44,000, as was done in the PHRI study, any outcome which happens six times in a million will not likely be observed.  Thus when jumping to the full population, numbering in the many millions, outcomes are possible which were not observed in clinical trials. Grown-ups ought to know this.

Thus the lawyers for the plaintiffs are going to engage in one or more logical fallacies and are going to try to prove that the scientists at PHRI and at Boerhringer Ingelheim didn't know what they were doing.  The lawyers are going to try to show that they, mere amateurs, are smarter than the scientific experts.  The scientific experts are experts in medicine, not the more obscure realms of logic.  I fear the trial will prove to be a farce of reasoning and argument.

I understand why Boerhringer Ingelheim is dragging its feet.  The plaintiff's lawyers have nothing to go on except the complaints of their clients and the inconclusive FDA report that Buist mentioned in his article.  They are engaging in a fishing expedition so that they can find some statement which in isolation proves to be sensational to their case.  The requirement by the judge that the company provide copies of "any possible derivation of means to document someone's thoughts, words, and deeds short of attaching electrodes to their scalps and electronically downloading what is contained in their minds" is almost inconceivably broad and would likely amount to millions of pages if completely fulfilled.  That is quite a burdensome administrative undertaking, disruptive and costly for the company and of no possible benefit to it.  No doubt some things will be left out, and the failure to deliver some obscure document will be held up as a sign of a guilty conscience and bad faith.  The note taking by the scientists will, in future, be conditioned by the fear that those notes may be subpoenaed as evidence.

Buist's account of the case was excellent.  I fear from his report that the trail will prove to be a farce and will unfairly blacken the reputations of some really good people.  Unfortunately, the lawyers for the plaintiffs will not be made to suffer for their misdeeds, and the trial judge will not be made to suffer for failing to act upon the observation that this case is a farce start to finish.

If you just want new drugs like Viagra, then by all means let trials like that over Pradaxa flourish. But if you want new medicines that treat serious illnesses, then these farce-trials need to be exposed for what they are: a bid for enrichment, first by the lawyers and then by the plaintiffs.
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