Last Updated Feb 10, 2011 9:23 AM EST
The letter is by far the most detailed account yet from a Pfizer executive about what happened during Pfizer's test of a meningitis drug on 200 children in 1996. Pfizer failed to get proper consent for the trial. Eleven kids died and the drug was eventually nixed for meningitis because it had a risk of complications. The events may have inspired the book and film, The Constant Gardener. Pfizer has attempted to do the right thing in recent years by settling a case brought by families affected by the test for $75 million, but it's been stymied by local bureaucracy and corruption.
Even before the trial began, approval from Nigerian officials came so quickly that one Pfizer employee didn't believe they had read the paperwork properly: "This will hau[n]t us," the employee said:
The letter was written by Dr. Juan Walterspiel, who in 1996 was a pediatric research physician in Pfizer's Groton, Conn., facility. He worked on the Trovan trials, but he objected to the testing method being used. Pfizer dismissed him in 1998. His letter claims that:
- Pfizer paid a bribe to continue the study of Trovan.
- Pfizer did not get informed consent from parents of children in the test.
- Pfizer gave fake ethics documents backing the test to the FDA.
- Corners were cut because "Speed was of the essence and stock options and bonuses at stake."
Pfizer ignored Trovan's poential reaction with antacids, which are often given to patients who have had surgery.
- The FDA started but mysteriously called off an investigation into the scandal.
- One patient in the Trovan arm of the experiment died without being taken off Torvan or given medical care. Normally, if patients react badly to experimental drugs researchers take them off the therapy and give them medical care.
- Pfizer has photographs of the members of its Kano team.
Dr. Juan Walterspiel's employment with Pfizer was terminated in 1998 for legitimate and proper reasons. Dr. Walterspiel did not travel to Nigeria to participate in the 1996 Trovan clinical trial and thus has no direct or first-hand knowledge of the conduct of the clinical trial. Dr. Walterspiel made these similar allegations over 10 years ago, and has repeated them from time to time since then. Pfizer investigated the allegations and found that they were not supported by the facts.Walterspiel's letter was based on an affidavit filed in the case in the early 2000s. At the time, much of the case was under seal and documents were not electronically filed, so Walterspeil's allegations went largely unnoticed beyond the lawyers who saw them. Walterspiel then wrote to former Pfizer CEO Jeff Kindler in 2007, repeating his claims. He sent a copy of that letter it to Judge William Pauley on Jan. 28, 2011, who entered it onto the record a few days ago.
Pfizer stands by the results of the Trovan clinical trial, which was conducted with the approval of the Nigerian governments, the informed consent of the study participants, and consistent with all applicable laws. The results of the study in Nigeria demonstrated that Trovan helped save children's lives."
The letter does not name names. Instead, Walterspeil uses numbers to stand in for the identities of the people he links to the Trovan trial. Three of them knew that Pfizer had sent a cash courier to some Nigerian officials who "needed to be paid off" before the trial could continue:
Pfizer had not obtained the proper ethics committee approvals before the test began, Walterspeigel claims. (Research on human subjects usually requires approval of an independent institutional review board before it can start.) So the paperwork was faked:
The older ruling supplies some of the names behind the numbers. A status hearing in the case is scheduled for Feb. 16. If it proceeds, Pfizer can expect more damaging evidence to come out. Even if the judge ignores Walterspiel's letter a second time, the plaintiffs can still use it as a guide to who to interview and collect documents from. Part of that investigation will focus on Pfizer's New York HQ.
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