Pfizer admits to testing on children without parental advisory

Disease outbreak exploited to test dangerous drugs

In modern medicine and healthcare, vaccines are considered essential for responding to epidemics and pandemics. However, around the world, many people choose not to be vaccinated for different reasons.

Some rely on their own immunity, while others distrust the government and the health authorities responsible for vaccination or vaccine development. Some people are also wary of vaccination campaigns because of past events.

In Africa, for example, only 23% of the population is fully vaccinated, a situation directly linked to the continent's history and experience with Western medicine^[1].

At the end of the last century, there was an outbreak of meningitis in Africa. The pharmaceutical giant Pfizer then decided to seize the opportunity to test the effectiveness of its Trovan drug, which was still being tested in children.

The result was tragic: deaths of patients, health troubles for survivors, and lingering doubts to this day about both Western medicine and the intentions of pharmaceutical companies.

Trovan testing in Nigeria ended tragically, and there are no culprits

In 1996, Nigeria experienced one of the worst epidemics of meningitis, an infection of the meninges, in the country's history, with 109 580 cases and 11 717 deaths.

At the time, the hospital in Kano, Nigeria, was staffed by medics from Doctors Without Borders, an international humanitarian non-governmental organization best known for providing medical aid to developing countries^[2].

They treated children with chloramphenicol, a well-known antibiotic approved by the World Health Organisation (WHO) to treat bacterial meningitis.

During the same period, the US pharmaceutical company Pfizer was trying to launch a new antibiotic drug, Trovan, on the market. Although Pfizer had tested the drug in adults, it had not yet been tested in children, and early trials in adults had shown serious side effects, including liver problems and cartilage damage.

When Pfizer became aware of the meningitis epidemic in Nigeria, it decided to take the opportunity to test the effectiveness of Trovan in children there. The pharmaceutical company set up a camp next to the Doctors Without Borders workplace, where it recruited 200 children aged between 3 months and 18 years over a period of two weeks. They took part in the study.

However, the study ended in tragedy. A month later, 11 of the children who took part died. In addition, many parents of the children who took part in the trial reported disabilities in their children, including paralysis and liver failure.

There were also many ethical dilemmas: after all, the Pfizer drug trials were conducted in the same hospital where Doctors Without Borders was based and where the doctors were actually treating the patients successfully and safely, but the pharmaceutical trials continued, even as the health of the children selected for the trial deteriorated.

Trovan is associated with serious side effects

Trovan was launched in 1998 and became a lucrative product for Pfizer, but was later withdrawn in Europe and restricted in the United States, with the drug linked to fatal cases of liver damage.

The US Food and Drug Administration had approved the therapeutic use of trovafloxacin (Trovan) for patients aged 18 years and over in late 1997, but in 1999, the agency advised doctors to limit its prescription because of adverse events. More than 100 cases of acute liver injury were then reported to the FDA. In May 2000, the FDA revoked the marketing authorization for the drug^[3].

The marketing authorization for trovafloxacin in the European Union (EU) was granted in 1998, and in 1999, the Committee for Proprietary Medicinal Products (CPMP) recommended that the marketing authorization be suspended for at least one year due to reported adverse events. In October 2000, Pfizer notified the European Commission (EC) of its decision to withdraw the marketing authorization voluntarily.

The drug is currently not approved for use in the USA and the EU because of its association with cases of acute liver failure and death.

Pfizer has still not admitted its guilt

It was not until 2000 that the Washington Post published a series of articles claiming that Pfizer was responsible for the death and disability of Nigerian children with meningitis, alleging that Pfizer had conducted unethical experimental studies without obtaining the informed consent of the study participants.

Parents of the affected minors claimed that they were not informed about the experimental nature of the trials, and many claimed that they thought they were receiving standard medicines dispensed by the Doctors Without Borders team. Pfizer denied any wrongdoing and claimed that the children died of meningitis and not from its drug.

Shortly afterward, an investigation by a team of experts hired by the Nigerian government found that Pfizer was indeed guilty of causing the children's deaths and of conducting tests on human subjects without their informed consent^[4].

In 2009, an out-of-court settlement was reached, which resulted in a payment of USD 75 million to the Nigerian state of Kano, which was the most affected by the disease and the tests, and a payment of USD 175,000 to the families of four of the dead children.

Despite the settlement of the case, the company still maintains to this day that the deaths and disabilities were caused by meningitis and not by its drugs. The company also claims that Trovan was first tested on 5,000 Americans and Europeans and that the drug then worked perfectly.

Pfizer also claims that Trovan has saved many lives in Nigeria, as 94% of Nigerian children who have received the drug have survived, more than the usual rate if the drug is not prescribed.

However, a secret State Department letter released by WikiLeaks in 2009 claims that a Pfizer official in Nigeria told American diplomats that the company had hired private investigators to uncover corrupt links to the former Nigerian Attorney General in order to pressure him to drop the Trovan lawsuits. "Pfizer has also denied this accusation.

Pfizer casts doubt on the efficacy and safety of all vaccines

These unethical drug trials have led to mistrust, particularly in Muslim communities. Nigeria has a majority Muslim population, and many believe that Western countries were deliberately targeting Nigeria because of the religion of its population.

Other factors included rumors that the polio vaccine contained the AIDS virus or that it was a Western plot to sterilize Muslim girls in order to curb the Muslim population, which the West perceived as a threat.

As a result, campaigns such as the Global Polio Eradication Initiative (GPEI) have subsequently been boycotted by Muslims in Nigeria, who have cited Pfizer's antibiotic trials as the reason for their lack of confidence in the Western countries that have brought the polio vaccine. This led to the failure of the global eradication of polio and to skepticism about other drugs and vaccines that followed.