Nigeria
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives traveled to Kano, Nigeria to administer an experimental antibiotic, trovafloxacin, to approximately 200 children. Local Kano officials report that more than 50 children died in the experiment, while many others developed mental and physical deformities. In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment. Representing the government is Babatunde Irukera. According to news reports, "esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug." The lawsuits also accuse Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Pfizer denied these claims, and subsequently produced an approval letter for testing from the Nigerian Ethics Committee. The Nigerian government insisted that it was a fake and a panel of Nigerian medical experts agreed that the letter had been concocted and backdated by the company's lead researcher in Kano. They went on to conclude that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to children and infants.
In 2007, Pfizer published a Statement of Defense letter. The letter makes several claims, including that Pfizer donated 18 million in Nigerian Naira (NGN) (about $216,000 in 1996 US dollars (USD)), that the drug's oral form was presented as safer and easier to administer, that the administration of Trovan saved lives, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.
A more likely reason for Pfizer's insistence on the oral form is the result of testing trovafloxacin intravenously in 1995, which found that the drug precipitated in saline, making it ineffective in patients receiving IV fluids. This is inferred from an FDA Warning Letter to ex-CEO William C. Steere, regarding Trovan's compatibility with saline etc., which was omitted from Trovan's labeling until January 1999, shortly after Pfizer received the letter.
In June 1999, the FDA released a public health statement warning against the use of Trovan except in life-or-death situations, due to high risk of liver failure. In some cases, liver damage occurred after only two days of treatment.
In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.
In December 2010, WikiLeaks released US diplomatic cables, which indicate that Pfizer had "used dirty tricks to avoid clinical trial payout". The company had hired investigators to find evidence of corruption against the Nigerian attorney general to persuade him to drop legal action. Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail." In response, the company has released a press statement describing the allegations as "preposterous" and stating that they acted in good faith.
Read more about this topic: Pfizer, Litigation