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The encyclopedia · R&D & Science · Operational decision · 1996–2009

Pfizer tested an unapproved drug on 200 Nigerian children — 11 died, families got $75M

During a 1996 meningitis epidemic in Nigeria, Pfizer tested Trovan on 200 children without consent. 11 died. Others blinded or deaf. Pfizer settled for $75M.

Pfizer · 1996-04

What happened

In 1996, a devastating meningitis epidemic swept through Kano, Nigeria, one of the poorest regions of the country. Thousands of children were dying. Pfizer saw an opportunity to test Trovan (trovafloxacin), a new experimental antibiotic that had never been used in children. The company sent a team to Kano and enrolled approximately 200 children in a clinical trial, comparing Trovan against an older antibiotic. The children did not receive the standard WHO-recommended treatment, which had a much higher survival rate.

Eleven children died — five who received Trovan, six who received the comparison drug. Other survivors suffered blindness, deafness, and brain damage. An investigation by The Washington Post later revealed that the trial was conducted without authorization from the Nigerian government and without informed consent from the children's parents. The lead investigator, Dr. Abdulhamid Isa Dutse, had falsified and backdated an ethics approval letter. Parents said they were told the children were receiving free medical treatment, not experimental drugs.

Families of the victims sued Pfizer in US courts between 2002 and 2005, but the cases were initially dismissed. In January 2009, the US Court of Appeals for the Second Circuit ruled the families could sue under the Alien Tort Statute. On 30 July 2009, Pfizer settled with the State of Kano for $75 million. Two remaining federal lawsuits were settled in 2011. Pfizer admitted no wrongdoing but agreed to pay compensation. The Trovan trial became a landmark case in research ethics, cited as an example of exploiting a public health crisis to test an unproven drug on vulnerable populations.

Why it happened

  • Pfizer tested an experimental drug on children during a humanitarian crisis without proper consent — parents were told their children were receiving free treatment, not experimental medication
  • The lead investigator falsified and backdated an ethics approval letter, meaning the trial had no legitimate regulatory oversight at any point
  • Pfizer did not administer the WHO-recommended standard treatment, which had a proven survival rate — the comparison drug was also experimental for children, doubling the risk
What it cost11 dead; survivors blinded, deafened, brain-damaged; $75Mcatastrophic

The lesson

A humanitarian crisis is not a waiver of ethics. When told 'free treatment' and children receive experimental drugs, the consent form says nothing about consent.

Aftermath

The Trovan trial is cited as one of the most egregious examples of exploiting a public health emergency to test an experimental drug. Pfizer settled for $75 million with no admission of wrongdoing. Trovan was later found to cause severe liver toxicity and was restricted globally. The case contributed to the debate about clinical trial ethics in developing countries and influenced the revision of the Declaration of Helsinki and CIOMS guidelines on research in vulnerable populations. Trovan is no longer marketed in most countries.

Sources

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