---

---

Leadership (Abuja)

Nigeria: Trovan - Kano, FG, Pfizer to Settle Out of Court

Gowon Emakpe

12 May 2008

---

As both Kano State and the Federal Government resume their legal battle against Pfizer Pharmaceutical Limited over a Trovan clinical study, which allegedly killed 200 children in Kano, there were strong indications during the weekend that the parties to the case might settle out of court.

The latest move, LEADERSHIP gathered last night, was as a result of the intervention of a respected traditional ruler from Kano State.

Since the filing of the first charges against Pfizer in connection with the 1996 Trovan clinical study, there have been media reports, within and outside the country, saying that about 200 were killed or injured.

But a source in the Kano State attorney-general's office said despite "exaggerated claims in many media stories" regarding the 200 children who allegedly suffered death or injury in the study, the Kano government cites 57 names in its amended criminal complaint, which means that 143 patients - nearly three-fourths of all the patients in the study, were not included in the complaint.

"So based on the government's own assessment, we are talking only about 57 patients, and there are many doubts and question marks about these," the source stated.

"A substantial portion of the 57 names cited in the complaint - at least one-third (18) and as many as two-thirds (42) - do not match the patient information included in the government's Nasidi report; in other words, as many as two-thirds of the patients named in the court case do not appear to have been in the study at all based on the patient information in the Nasidi report that lists the initials for all 200 study participants, of the 57 separate individuals named in the Kano clinical complaint, 18 do not match at all the initials and/or gender listed in the patients list in the Nasidi report."

"If one assumes that the first initial should match the first name and the second initial should match the middle or last name from the patients list, then there are at least 22 people for whom there is no possible match. If one assumes that the first initial should match the first name and the second initial should match the last name from the patient list, then there are at least 42 people for whom there is no possible match".

The source, a lawyer in the attorney general's office, added that no one should conclude from this analysis that the remaining patients whose initials match participated in the study, saying, "Given the significant number of patient names in the complaint that do not appear to have been in the study, any reasonable individual would conclude that there are serious questions about the accuracy of the Kano government's claims".

"In all the cases related to the Trovan clinical study, the government has the burden of proof and must prove not only that these patients were in the study, but also that Pfizer knowingly injured them", the source said.

LEADERSHIP gathered that no other case better illustrates the seeming inaccurate claims that have been raised in connection with the governments' cases than that of one Anas Mohammed. "From June 2007 to March 2008, Anas was featured in at least seven local and international media outlets even though he is not mentioned in the Kano government's criminal complaint", the Kano State official said.

The problem with Mohammed's case according to our source, was "fully exposed" when on November 12, a German publication, Der Spiegel, published a lengthy article on the Trovan clinical study. The piece identifies the said Mohammed as patient No.1, who was treated with Trovan and suffers brain damage. But LEADERSHIP gathered that an accompanying picture of Mohammed holding his pink patient card unmistakably contradicts that allegation. The pink card our source added, "clearly identifies him as a patient who was treated with Ceftriaxone, the gold standard medication against meningitis at the time and still today. And on November 24, a correction appeared on the Der Spiegel web site.

"In summary, there are serious questions about the patients named in the government's complaint as many don't appear on the list of 200 patient initials included in the Nasidi report. Similarly, serious questions also should be raised about Anas Mohammed and other stories in support of the cases that have been pushed with the media," the source stated.

"This case is not about whether the government approved the clinical trial - which it did; it is not even about the effectiveness of Trovan - Trovan performed at least as well as Ceftriaxone, the gold standard medication still today against meningitis. Instead, this case is about whether there was a conspiracy - meaning two or more people working together or having a plan regarding the Trovan clinical study.

"It is about whether the plan or alleged conspiracy was conducted with the knowledge that it would likely harm people or cause death.

"Among the many allegations that Pfizer had been accused of, are that: Pfizer did not have government approval for the trial; parents did not provide consent for children's participation; elevated numbers of deaths; that Trovan caused the death of patients and serious side-effects in survivors and Ceftriaxone was administered in a lower dose. But Pfizer has consistently argued that before conducting the Trovan study in Kano, it sought and obtained all necessary approvals from relevant Federal and state government agencies in Nigeria.

"The High Court, Kano State has ordered the State and Federal Governments to produce more than 12 letters between Pfizer and the two governments in connection with the clinical study. The letters were said to have shown that contrary to the governments' allegations, Pfizer obtained approval for the study from both governments. The order of court, dated April 24, was in response to a request by one of the individual defendants in the case to subpoena the letters.

"The principal investigator of the study, Dr. Isa Dutse, a Nigerian physician "with impressive qualifications and substantial experience in epidemic situations", was said to have proved that Trovan helped save lives. "With a survival rate of 94.4%, trovan was at least effective as the best treatment available at Kano's Infectious Disease Hospital (IDH)", the source stated.

"The results of the study point to the efficacy of the comparator drug, Ceftriaxone, at the doses administered. After the initial dose of 100-mg/kg doses, subsequent doses of Ceftriaxone were reduced to 33mg/kg to diminish the significant pain resulting from the intramuscular injection. At the reduced dosage level, the amount of the drug was still approximately 620 times the level required to kill the meningitis bacteria. Ceftriaxone's survival rate (93.8%) of approximately 94% speaks to how effective the comparative drug was at the doses administered".

"The prosecution cannot possibly prove that the study participants received an inadequate dose of Ceftriaxone. The subsequent Doctors Without Borders (DWB) study confirms this simply is not true".

"At the end of the study, any child who required additional attention was transferred to a local Kano hospital for continued care at Pfizer's expense. Four weeks after concluding the study - on May 15, 1996 - Pfizer conducted a follow-up examination of study participants. The patients who returned for the examination observed no unusual side effects, unrelated to meningitis.

"All the medical evidence points to the disease as the cause of deaths - five in the Trovan arm and six in the Ceftriaxone arm - or the serious health conditions of the survivor patients. It is well documented that survivors of meningitis can suffer long term complications, including, but not limited to, brain damage, hearing loss, mental retardation, paralysis and seizures.

"We have a complex case in our hands; and we don't want to delay this case".

Read comments. Write your own.

---