Pfizer and the Nigerian Trovan SuitThere 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.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)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.
“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, “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. “Prior to treatment, informed consent was obtained.
” Patients’ families were also informed of the “nature and risks” of the trials and told that they could discontinue treatment and seek an alternative at any time. Pfizer had no financial incentive in mind, only to “allow the availability of trovafloxacin for medical and philanthropic use in the treatment of future epidemics.”The plaintiff families claim that Pfizer is responsible for 11 deaths and injuries to other children.
It has also been said that “Pfizer hurried to Kano to exploit the misfortune there for its own benefit.” (Reliefweb) Pfizer is accused of not obtaining parental consent, not informing patients of better alternatives and their “actions constituted torture and inhuman punishment.”(WashPost) I believe that Pfizer went to Nigeria with the best intentions. Only eleven deaths seem natural when dealing with a disease that claims thousands. It wouldn’t make any sense to claim that Pfizer would benefit from developing a drug that could only be used in poor, under-developed countries. It is obvious they only intended it for human benefit.
Pfizer states that The Washington Post was in contact with the company seeking information and they fully cooperated in providing requested materials. “The company provided extensive responses to several inquiries from The Post over the past two months, provided positions on Pfizer clinical work in Europe, Central and South America, and Nigeria, and ensured that The Post had access to physicians who led the Nigeria trial.” (Pfizer) It seems that The Post wanted a big story and mangled the facts along the way. Pfizer provided an in-depth report about the experiments, denying all accusations and presenting proof.
The Post only presented bits and pieces of facts meanwhile wholly presenting the side of the Nigerian families. As for these families, this is an opportunity to make more money then they can imagine.