Healthy Skepticism Library item: 19103

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E
Former Pfizer Doc Renews His Trovan Allegations
Pharmalot 2011 Feb 10
http://www.pharmalot.com/2011/02/former-pfizer-doc-renews-his-trovan-allegations/

Full text:

Some scandals will just not go away. Consider the Trovan affair. In recent months, a cable disclosed by WikiLeaks indicated Pfizer hired investigators to use ‘dirty tricks’ to force the Nigerian government into a settlement (see this). A group of Nigerians and their families filed a lawsuit against the drugmaker for $384 million over their unhappiness with settlement requirements (read here). And now, a former Pfizer employee has written a federal court judge with his own account of alleged misdeeds surrounding the episode, which began back in 1996.
Ironically, these latest developments occurred after Pfizer agreed to a $75 million settlement to resolve civil and criminal charges brought by the Kano State government in Nigeria, and hoped the matter would end. For those unfamiliar, a 1996 Trovan study was conducted on about 200 children and took place during a meningitis epidemic that killed 12,000 children, but Nigerians claim Pfizer failed to obtain proper regulatory approval for the antibiotic trial and misled parents. The study allegedly left 11 children dead and others deformed. Pfizer denied wrongdoing.
However, Juan Walterspiel, who at the time worked as a pediatric research physician at the Pfizer R&D facility in Groton, Connecticut, late last month forwarded a sensational letter to US District Court Judge William Pauley, who is presiding over ongoing, separate litigation filed by Nigerian families in New York. The letter, which was first reported by Corporate Counsel, was originally sent to former Pfizer ceo Jeff Kindler in 2007.
We asked Walterspiel, who worked on the Trovan trial but objected to the protocol, why he wrote to Pauley on January 28. He responds that he was moved to do so after the WikiLeaks report two months ago and a German newspaper subsequently wrote about the episode with reference to his original letter (see that story here, although it helps to read German). “You asked for a reason? For the truth to be revealed, justice to be done and human dignity to be preserved, even when ones own country is humiliated and ridiculed by a more powerful entity.” He also bristles at the notion that Pfizer “considers breaking the law as a minor business expense,” a reference to the $2.3 billion fine paid in the US for off-label marketing.
In his letter, he offered a rather detailed, if somewhat dense account of what he alleged were nefarious behind-the-scenes doings. Among his charges: the drugmaker allegedly submitted phony ethics documents from Nigeria to the FDA; ignored the potential for the antibiotic to interact with antacids that are often given to patients after surgery; did not provide families with informed consent info for children to participate in the trial; apparently bribed foreign officials and otherwise engaged in behavior that “may have led to criminally negligent homicide.” Not surprisingly, he tells us he used numbers, not names, in order to protect identities.
For instance, there is this passage: “While the team was in Kano, (employee) 8 and (employee) 9, with 8 having refused to participate in the study, received a teleconference phone call from (employee) 10 reporting that Nigerian officials had shut down the study, needed to be paid off and that the team was under the threat of arrest. A currier [that was his spelling mistake, not ours] with cash was dispatched by intervention of (employee) 9 via KLM through Amsterdam. The study resumed about three days later” (you can read the complete letter here)
To what extent his allegations will be explored anew is unclear. As Corporate Counsel notes, there is a status hearing in the litigation next week. But the assertions were rejected by the same judge in 2005, who at the time wrote that “Dr. Walterspiel’s declaration makes it abundantly clear that his allegations of bribery are speculative and not based on personal knowledge” due, in part, to the fact that he was based in Groton and did not travel to Nigeria (read the order). Nonetheless, Pauley did choose to submit the letter into the official record, a move that he might have guessed would stir the pot, so to speak.
As for Pfizer, the drugmaker dismissed the allegations. A Pfizer spokesman sent us this statement: “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.”