State and federal governments in Nigeria are being asked by a state court there to produce more than a dozen letters between Pfizer and various government agencies that allegedly indicate the drugmaker was given permission to conduct its controversial 1996 trial of the Trovan antibiotic, This Day reports, citing a a statement from the drugmaker.

At issue are charges that Pfizer illegally conducted an unauthorized trial on more than 100 children at a government hospital during a triple epidemic of measles, cholera and meningitis in which 12,000 people died. The episode led to the death of 11 children and various deformities - including deafness, blindness, paralysis and brain damage - in 189 others. Pfizer denies doing anything illegal and insists government permission was granted.

For the past year, the drugmaker has been fighting civil and criminal charges in both Kano state court and federal court in Nigeria. The federal government, in fact, wants to pursue criminal charges against several former and current Pfizer personnel. And topping the list is Bill Steere, the former ceo who still sits on the board and has been threatened with a summons to appear in Nigeria.

The letters purportedly indicate that, contrary to government allegations, Pfizer sought and obtained government approval to conduct the Trovan study before the trial got under way, according to a Pfizer statement, which adds that the Kano state court’s April 24 order was in response to a request by one of the individual defendants in the case to subpoena the letters.

Separately, Agence-France Presse reports talks are still under way between Pfizer and Nigeria, and that a source says Pfizer offered to pay $10 million to the alleged trial victims, upgrade a hospital where the trial took place and build a pediatric ward in another hospital, but Kano insisted on $1 billion in compensation to the victims and $750 million in damages. Kano had initially demanded $2.75 billion compensation but never disclosed a proposed breakdown. A state official called Pfizer’s offer “ridiculous.”

“Government approval is at the heart of these cases. Pfizer has said all along that both the Kano State and federal governments were fully aware and approved of the Trovan clinical study. Now, the Nigerian people can confirm that with their own eyes,” Pfizer spokesman Chris Loder says in the statement.

According to the Pfizer statement, one of the subpoenaed documents is a March 20, 1996, letter from Nigeria’s National Agency for Food and Drug Administration Control (NAFDAC) - the Nigerian authority responsible for approving clinical studies - to the US FDA), providing approval for Trovan to be used as part of a clinical study.

The letter reads in part: “We have been supplied with adequate information about the drug and its proposed investigational use by the sponsor. The drug will be used for investigational use only. The drug may be legally used by the investigators in Nigeria.” Years later, in response to an inquiry by a federal government committee investigating the matter, NAFDAC again confirmed that it had approved the Trovan clinical study.

“Available evidence show that in 1996, NAFDAC legally granted permit to Pfizer Plc. to import the un-registered drug, Oral Trovan, into Nigeria, for the purpose of clinical trial investigations,” says the January 5, 2001, letter.

Other letters between Pfizer and federal authorities show: the Federal Government’s invitation to Pfizer to come to Nigeria; an exchange between the Federal Ministries of Health and Finance seeking to facilitate the entry of Pfizer medicines and medical supplies into Nigeria via the ports; and the authorization to import Pfizer medicines and other medical supplies duty free.

The letters between Pfizer and Kano State authorities also address various issues, including the state’s authorization for Pfizer doctors to treat patients. “Approval is also hereby given for your staff to participate in treating patients at our hospitals,” reads a letter from Kano’s Ministry of Health to Pfizer Products Plc. dated April 2, 1996.