WikiLeaks: Did Pfizer Use Unethical Tactics to Evade a Clinical Trial Settlement?

The latest WikiLeaks targets are Pfizer and Shell. According to diplomatic cables, the companies may have used unethical tactics to influence the Nigerian government.
The latest WikiLeaks targets are Pfizer and Shell. According to diplomatic cables, the companies may have used unethical tactics to influence the Nigerian government.

As expected, WikiLeaks is targeting companies now. While we're still waiting for the promised leaks on a big U.S. bank, the whistle-blowing site revealed documents about oil giant Shell and the world's biggest pharmaceutical company Pfizer (PFE) -- both related to operations in Nigeria, The Guardian reported Thursday.

The Pfizer-related cable hails from 1996, when a severe meningitis epidemic struck the north of Nigeria. In the midst of all that, in a hospital overrun with cases in the town of Kano, Pfizer showed up to conduct a trial of an oral antibiotic called Trovan, which it tested against the "gold standard" treatment of the western world, ceftriaxone. Pfizer dosed 200 children, half with Trovan and half with ceftriaxone.

Trial Results

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Eleven children in the study died: five who took Trovan and six who took ceftriaxone. This was a better death rate than the untreated epidemic. But Nigerian authorities said Pfizer did not have proper consent from parents to use an experimental drug on their children. Some parents also alleged that the trial left their children paralyzed, deaf, mute or blind. Trovan, which was licensed in the U.S. and Europe for other uses, has since been withdrawn because of fears of liver toxicity. Nigeria later sued Pfizer, seeking $8.5 billion in restitution and damages, according to Forbes.

Thirteen years after the study, Pfizer finally reached a tentative settlement of $75 million in 2009 with the Kano state government. That's a tiny fraction of the $50 billion in revenue and $8.6 billion in net income that Pfizer posted that year. Still, Pfizer didn't want to pay, according to a U.S. embassy cable that reports a meeting between Pfizer Nigeria Country Director Enrico Liggeri and U.S. officials in April 2009.

Liggeri said Pfizer was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15 million a year in legal and investigative fees.

More seriously, the cables also suggest that the drug giant hired investigators to find evidence of corruption against the Nigerian attorney general in order to convince him to drop federal legal action against the company.

According to Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media, XXXXXXXXXXXX. A series of damaging articles detailing Aondoakaa's "alleged" corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa's cronies were pressuring him to drop the suit for fear of further negative articles.

Settlement Raises Questions

In October 2009, Pfizer and Nigeria agreed to settle the federal allegations: The government agreed to dismiss the civil and criminal actions with prejudice -- meaning it can't refile the same cases -- and Pfizer agreed to pay the government's legal fees and expenses, according to the company's 10-Q filing. It's still unclear why Nigeria dropped these cases.

These cables emerge as WikiLeak's Julian Assange remains in prison over rape charges and as WikiLeaks supporters have conducted cyber attacks against MasterCard (MA), Visa (V), eBay's (EBAY) PayPal and other organizations that have cut off funding for the site.

As of press time, Pfizer hadn't responded to requests for comment from DailyFinance, but it had told The Guardian: "Pfizer negotiated the settlement with the federal government of Nigeria in good faith and its conduct in reaching that agreement was proper. Although Pfizer has not seen any documents from the US embassy in Nigeria regarding the federal government cases, the statements purportedly contained in such documents are completely false." Pfizer added that it denies "any wrongdoing or liability in connection with the 1996 study."

Regardless, the case highlights the potential pitfalls of conducting clinical trials in foreign countries, especially in the developing world. The problems involve not just human rights matters, but medical issues and concerns about whether results from a different area would be relevant to the U.S. population. In spite of those challenges, VanityFair reveals that the number of overseas clinical trials has been increasing.

As for oil giant Shell, the cables suggest it claimed it had "inserted staff into all the main ministries of the Nigerian government, giving it access to politicians' every move in the oil-rich Niger Delta, " The Guardian also reported.

The Guardian has posted WikiLeaks documents in easy-to-read format here.

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