Whistleblower News & information

Last Thursday, June 21, 2012, the American Enterprise Institute held a panel, entitled “Muzzle pharma, harm patients: The dangers of anti-industry bias.”  Sitting on the panel were George Chressanthis, a professor at Temple University, Nitin Jain, a principal at ZS Associates headquarters, Thomas Stossel, a hematologist and oncologist, and J.D. Kleinke, a health care business expert.  The panel presented a new study which aimed at determining the relationship between physicians’ choices of drugs and their access to sales representatives from pharmaceutical companies.  The study looked at between 58,000 to 72,000 cases for three different drugs, Januvia, Vytorin, and Avandia, in an attempt to cover a broad range of cases which would inspire a change in drug choices.  Januvia was their sample for a first-in-class drug, Vytorin, for a negative clinical trial, and Avandia, for an FDA imposed black-box warning.  All the physician and prescription information for the cases were provided by the pharmaceutical companies and no patient outcomes were evaluated.  The study found that, generally, doctors take longer to change to first-in-class drugs but also take longer to switch away from drugs that had a negative clinical trial or for which the FDA had issued a black box warning.  Ultimately, it concluded that access limits are a part of an institutional framework whose anti-industry bias, manifested in access limits, have harmful consequences for patients.  Doctors need to operate from the largest body of information, they argued, and that to restrict them from information in any way adversely affects patient health.

Though the study presented clearly and incontestably that access to representatives caused a change in how physicians made decisions regarding drugs, without a further study of patient outcomes, there’s no basis from which to decide whether or not these changes were productive or effective.  The panel wanted to say that doctors should not rely solely on sales reps for their information but at the same time wanted to say that these same sales reps made a significant impact on physicians’ decision-making procedure.  The intimated bias was that these changes were positive changes, but without more concrete data on the practical results of these prescription changes, it is impossible from this study alone to judge decisively whether access limits have unintended and adverse consequences for patient health.