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Report on Prevnar Study Death in India Raises Concerns About Overseas Drug Trials

Mar 23, 2009 | Parker Waichman LLP

A baby girl in India who died last year during a clinical trial for the Wyeth vaccine Prevnar succumbed because of "supervisory shortcomings", not because of problems with the vaccine.  According to The Wall Street Journal, the result of an Indian investigation  into the child's death will likely raise more questions about how well Western pharmaceutical companies oversee drug clinical trials in developing countries like India.

As we reported last year,  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.  

Now the Wall Street Journal is reporting that  the girl  never should have been allowed to participate in the trial.  According to a report from the  Drugs Controller General of India, the child's medical file indicated that a sibling had died of a cardiac problem at four months of age.  The Journal said that fact should have been a "red flag" that prompted medical personnel involved in the Prevnar trial to test the infant for a heart condition.

The dead child's medical records also indicate that when she was given the third Prevnar dose, she had a cough and diarrhea.  She still got the vaccine.  According to the Journal, the  baby was admitted to the pediatric ward less than a week later with a cough and noisy breathing. A chest X-ray revealed an enlarged heart. A day later, she died of cardiac arrest, the investigative report says.

The Drugs Controller report raises serious questions about the supervision and competence of those who were involved in the Prevnar trial.  Such concerns have arisen about other drug clinical trials in that country.  According to the Journal, 46 children in clinical trials at New Delhi's All India Institute of Medical Sciences died.  Investigations have revealed that the child deaths were the result of underlying medical conditions.  However, the outcry over the deaths have prompted Indian regulators to scale back  a plan that would have loosened rules for clinical trials, The Wall Street Journal said.

Countries like India welcome drug clinical trials, the Journal said, because they can provide cheap health care for the needy and give access to experimental medicines sought by some dying patients.  But critics complain that drug companies are exploiting needy and desperate people.  According to the Journal, One group, the entre for Studies in Ethics and Rights in Mumbai said in a February report that some trials conducted in India don't meet international standards of good clinical practice even though they don't appear to violate the country's regulations for research.

For its part, Wyeth has  offered a detailed plan to Indian regulators to correct problems identified at the Bangalore hospital where the death occurred.  The company has also asked Indian authorities to allow it to restart Prevnar trials at sites other the Bangalore hospital that were halted as a result of the infant death.

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