Health Care Renewal in its May 3,2006 posting quotes a Wall Street Journal article that reveals alarming information about one drug trial involving telithromycin(Ketex),a macrolide antibiotic recently incriminated in causing serious liver toxicity and one that has been heavily promoted in various free "educational" publications and talks by infectious disease "thought leaders".
Physicians have probably to some degree become accustomed to looking more carefully at drug trials-when they have time to do it-to watch out for the usual bag of tricks, such as comparing the highlighted drug with an inadequate dose of a comparator drug. However, presenting outright bogus data-such as fabricated "patients" is a different level of egregious behavior.
HCR calls attention to the role of a contractor company,Pharmaceutical Product Development,INC (PPD) that facilitates and organizes -among other things-drug treatment trials as the most blatant culprits in this saga were private practice docs.
The story in a nutshell is that at least two of the private physicians taking part in the trial apparently fabricated data. Questions arise regarding the adequacy of oversight by both PPD and the contracting Big Pharma company, Sanofi-Aventis and the FDA conduct in the approval process will likely generate criticism as well. One of the doctors who ran a weight control practice somehow managed to enroll 30 new patients a day (the patients were supposed to have a respiratory tract infection requiring antibiotic therapy).The physician was subsequently convicted of mail fraud in regard to her activities in this trial.
As the investigation unfolds we will likely hear from both PPD and Sanofi-Aventis that they did everything according to the usual rules of research conduct but the bottom line seems to be that a drug was approved by the FDA and data from a very flawed trial may have been used to attest to its safety.
Randomized clinical trials (RCT) may be able to serve us well in the setting of determining the efficacy of a drug but the label of RCT on a publication does not tell us anything about the integrity of the data which in this case seems corrupted by fabrication. Fraud, lying and cheating may be harder to detect than statistical slanting of the data.
To me,the worse part of this sad story is that the most flagrant behavior was exhibited by private practice doctors.