Pfizer Drug Suit :: essays research papers

Pfizer and the Nigerian Trovan Suit   Ã‚  Ã‚  Ã‚  Ã‚  There has been a controversy about the experimental testing of the drug Trovan (trovafloxacin), by Pfizer, a major pharmaceutical company. Pfizer held clinical trials of the drug in Kano, Nigeria, during the 1996 epidemic of bacterial meningitis. The experiments were conducted on 200 children and were said to be successful. Recently, 30 Nigerian families of the children used in the experiments filed a lawsuit against Pfizer claiming they had violated laws by not obtaining permission from the families. (Reliefweb) This lawsuit is unprecedented. I believe Pfizer handled this experiment with good intentions and the press, namely the Washington Post, has unfairly portrayed them.   Ã‚  Ã‚  Ã‚  Ã‚  The Food and Drug Administration (FDA) has recently restricted the use of the antibiotic, Trovan, after it has been proven to cause liver failure and a small number of deaths when prescribed for many types of infections. Doctors were warned to reserve the use of Trovan for use only in the treatment of patients who meet very specific requirements. (Branch Law) Although it is harmful when used for certain ailments, Pfizer reports that Trovan has proven to be effective in treating meningococcal meningitis. This was determined during the experiments in Nigeria which were supervised by both American and Nigerian doctors. (Pfizer)   Ã‚  Ã‚  Ã‚  Ã‚  This experiment took place in Africa because of its recurring meningitis epidemic, which kills thousands of people. Pfizer took the opportunity to compare Trovan with ceftrixone, which was the commonly used drug at the time, to prove its effectiveness. One hundred patients were given Trovan and another 100 ceftrixone. In each group ninety-four percent of patients survived. â€Å"This mortality rate of 6% for both patient groups was lower than that seen in †¦patients with non-epidemic meningitis (range 6-10%), and lower than the overall fatality rate for this particular epidemic (10-30%).†(Pfizer) The incidence of side effects while using Trovan was not any higher than with ceftrixone. Oral Trovan proved to be a very safe, useful and promising treatment for this disease as compared to using other methods, which had to be given intravenously and could spread hepatitis or HIV. Pfizer states that, â€Å"The trial was designed and conducted in accordance with good medical practice and ethical norms.† They also said that both the Nigerian Ministry of Health and a local Nigerian ethics committee approved the experiment and a copy of this was sent to the FDA. â€Å"Prior to treatment, informed consent was obtained.