Pfizer Incorporated: Trovan or Trovafloxacin - Essay Example

Trovan
Trovan of Pfizer, an unapproved drug, was administered in children at the hospital of Kano in 1996, which came to the public attention only in December 2000.
Pfizer picked approximately 200 children for their clinical trial, of which 100 children were administered with Trovan whereas the other half was treated with the standard anti-meningitis drug Ceftriaxone that also acted as the control group. The children who were treated with Ceftriaxone, a cephalosporin antibiotic, were given an initial dosage level of 100 mg/kg dose which was subsequently reduced to 33 mg/kg to reduce the pain caused by intramuscular injection. These children, who had reached the hospital for their treatment of meningitis, were hand-picked randomly by the doctors of Pfizer. These children were also given tags to identify the drug they received. These two batches of children continued their treatment with Trovan and Ceftriaxone for five consecutive days and were monitored either in the hospital or out-patient clinics, depending on their health. Those children who required additional care were transferred to another hospital at the expense of Pfizer. The study was concluded after four weeks and a follow-up exam was conducted by Pfizer.

The results at the end of the trial conducted at Kano IDH recorded a survival rate of 94.4% at Kano's IDH against the overall survival rate in Nigeria of 90%. However, this anti-meningitis trial treatment was not devoid of mortality issues. Five children out of 100 children treated with Trovan and six out of 100 children treated with the standard drug Ceftriaxone died after the treatment. Though the follow-up conducted by the Pfizer team reported that there were no unusual side-effects, unrelated to meningitis, the children treated with Trovan did develop symptoms of arthritis, though no evidence relating the drug to this development is available.

Trovan was being developed for its release in the United States in the year of 1996 when Pfizer conducted a Nigerian trial. In the view of the panel of Nigerian medical experts, the act of testing an unregistered drug on children by Pfizer was “a clear case of exploitation of the ignorant” (Stephens para. 4). This panel points out that the trial of unapproved drug Trovan is a clear violation of Nigerian law, the International Declaration of Helsinki, and the U.N. Convention on the Rights of the Child.

Pfizer states that as per their studies on Trovan, which was conducted in more than 5000 patients in the United States and Europe, it was found that the drug was effective against various strains of bacteria that cause meningitis. The FDA though gave approval for the use of Trovan in adults in 1997, did not approve its use in the treatment of children. Trovan became the most prescribed antibiotic in a short span in the United States. But, in the year 1999, FDA restricted the use of Trovan based on the reports associated with Trovan, which indicated the occurrence of side-effects such as liver damage and death. These reports also prompted the European regulators to ban Trovan.

The federal government in 2007 filed a suit against Pfizer Inc. in the Nigerian Federal High Court, seeking US$6.95 billion in damages. The victims as well as the families of Trovan's clinical study also attempted to bring legal actions against Pfizer in the United States and they were entitled to bring suit against Pfizer in the United States under the Alien Tort Statute. In February 2011, the cases between Nigerian victims and Pfizer were laid to rest when both the parties involved agreed to settle down the cases. As per the settlement agreement, all the plaintiffs are required to join the Healthcare/Meningitis Trust Fund, which is being processed in Kano of Nigeria. As per the settlement agreement Pfizer Inc. agreed to compensate the damages of participants in the Trovan clinical study of 1996. The families of the participants as well as the survivors of the Trovan trial, in order to avail the compensation, are hence required to undergo the verification process that takes account of identification cards, physical appearances, medical records, photographs from the 1996 clinical trials, and also the analysis of identification details with those marked in the records of Trovan Trial of 1996. The identification process also requires DNA analysis to confirm the identity of the claimant as to the participant of the Trovan trial or kith of the participant.