Overseas Drug Company Clinical Trials Face More ScrutinyDec 2, 2008 | Parker Waichman LLP
Overseas health regulators are beginning to take a closer look at drug clinical trials conducted in their countries, following several well-publicized safety scandals, The Wall Street Journal reports. The crackdowns have cheered many patient advocates, who say the growing reliance on overseas studies by Western drug companies raises ethical concerns.
According to The Wall Street Journal, the death of an Indian infant during a trial for Prevnar-13, a pneumococcal vaccine being developed by Wyeth, prompted officials in that country to shut down the study. The child died within a week of receiving the third dose of the standard (not the experimental version) Prevnar vaccine. Indian drug regulators investigating the death found evidence that the baby had a pre-existing cardiac disorder that should have disqualified him from the trial.
While India halted the Prevnar-13 trial, other countries where Wyeth is conducting similar studies allowed those to continue.
The Wall Street Journal also reports that Polish regulators are scrutinizing a Novartis clinical trial for a bird flu vaccine after two elderly patients died. Age limits should have excluded both from the study. The investigation found that subjects for the trial were recruited at a nursing home and homeless shelter. That prompted investigators to notify the European Medicines Agency and the Polish Police.
While no link between the deaths and vaccine has been found, the recruiting irregularities are being investigated. According to the Journal, criminal probes of some of those who enrolled patients is continuing. Meanwhile, the problems have led to a delay of at least a year in approval of the vaccine by European authorities, the Journal said.
The Wall Street Journal article said 40% of trials sponsored by the global pharmaceutical industry in 2005 were conducted in low- and middle-income countries. That practice has been controversial in some quarters. Overseas trials are cheaper for drug makers, mainly because the personnel who conduct them can be paid less. But as the Wall Street Journal notes, critics charge some of these lower paid doctors and clinicians might feel pressured to boost enrollment or reconcile questionable data in order to keep drug company sponsors happy.
There's also a growing concern in less developed countries about their citizens being used to test new drugs that they will not be able to afford once they come to market, the Journal said.
Despite the increased scrutiny faced by drug companies conducting clinical trials overseas, the pharmaceutical industry shows no signs of abandoning overseas studies. According to The Wall Street Journal, India has approved some 450 clinical trials this year, up from about 100 in 2005. Wyeth also told the Journal that about 45% of its mid- and late-stage trial participants now come from outside the U.S. and Western Europe.