The klieg lights are on Big Pharma again, this time after 3 people died during drug trials in India and Poland.
The Polish case involves two nursing home residents that died after receiving Novartis’ experimental bird-flu vaccine. Both should have been excluded based on advanced age. The deaths and other glitches forced Novartis to delay the vaccine’s approval process by at least a year.
In the Indian case, investigators are trying to determine whether a baby who died after receiving Wyeth’s pneumococcal vaccine had a pre-existing heart condition that should have excluded it from the trial.
Neither company nor their vaccines are implicated in the investigations, but the problems highlight risks associated with drug trials in developing nations, where supervisors often feel pressure to increase enrollment, cut costs and scrub data to curry favor with Big Pharma.
In 2005, 40% of drug trials were carried out in developing nations, according to the Centre for Research on multinational Corporations (SOMO).
The number is higher now. India alone for example approved 450 drug trials this year. That’s 400% more than 2005.
Drug trials are inexpensive in low-income nations because the salaries of physicians and clinical personnel are lower. It’s also easier to recruit patients since participation in a trial is for many the best opportunity to access care.
In addition, these people are often not taking other medications, a critical entry criterion for many trials.
For its part, Big Pharma claims its trial designs are independent of venue and that it complies with local laws. It even assures participants can keep taking their medicine after the trial ends.
Assuming it proved to be safe and effective, that is.