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Healthy Skepticism Library item: 19177

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

Jack A, Burgis T
Pfizer calls WikiLeaks cable ‘preposterous’
The Finanical Times 2010 Dec 11
http://www.ft.com/cms/s/0/a57be4ea-0483-11e0-a99c-00144feabdc0.html


Full text:

Pfizer has dismissed as “preposterous” claims that it ran a “dirty tricks” operation to scuttle a Nigerian federal lawsuit, as the US pharmaceutical group struggles to compensate people affected by a clinical trial it ran in 1996.

A cable from the US embassy in Nigeria last year released on WikiLeaks via the UK’s Guardian newspaper claimed that Pfizer’s country director had hired investigators to uncover corruption allegations concerning the federal attorney-general and feed them to the local media.

The company was pursued by the federal government and the Kano region, where it tested its experimental antibiotic Trovan during a meningitis epidemic, achieving better results than the standard treatment but allegedly failing to meet ethical standards. A Nigerian government commission claimed the company had failed to seek regulatory and research ethics committee approval for the trial in advance, or to obtain participants’ written consent to take part.

The company, which has always denied any wrongdoing, rejected outright suggestions of influencing a federal litigation, which it concluded last October by paying only the government’s legal fees after intervention from Yakubu Gowon, the former head of state. Michael Aondoakaa, the then attorney-general, has also denied corruption charges.

Pfizer is still struggling to ensure a $75m settlement it concluded with the Kano regional authorities last April is fairly and transparently disbursed.

The company has recently begun work on a $30m clinic in the area, but has been blocked by a fresh legal appeal from paying out the remaining $35m to a trust fund on behalf of participants in the Trovan trial.

More than 600 people claimed compensation, although less than 200 participated, forcing Pfizer to propose DNA testing, which has been rejected by some of the claimants and has delayed payments.

Out of the 190 infected children who took part in the Trovan trial, in which the drug was tested against the existing approved treatment ceftriaxone, 94 per cent survived – compared with an average 60 per cent survival rate for the infection when untreated.

Trovan performed marginally better than its rival, with five deaths among the 93 children who took it, compared with six deaths out of the 97 who received ceftriaxone. No link was clearly demonstrated between the deaths and the drugs.

Pfizer researchers had hoped Trovan would provide a more effective and easier treatment for meningitis, but the procedural problems and subsequent side effects led US and European regulators to forbid its use on children.

 

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