Friday, February 12, 2010

Pfizer - Trovan: an editorial

Lagos — THOUGH the recent call by pharmaceuticals company, Pfizer on anyone with proof of participation in its 1996 Trovafloxacin Mesylate (Trovan) test in Kano, to come forward for a claim of USD175, 000 per person (about N26m each), is a welcome development, the amount is mere pittance when compared to the criminal damage Pfizer did to the victims of their test in Kano state.

About 200 people in the state took part in the test, which resulted in the death of 11 patients and permanent incapacitation of others.

Pfizer, towards effecting the out-of-court settlement reached, says claimants must come forward with proof of death or permanent incapacitation before they could be compensated. In fact, Pfizer has demanded a Deoxyribonucleic Acid (DNA) report as a pre-condition for beneficiaries to draw down on the $75 million judgment money against it.

Pfizer apparently is insisting on this position considering that the trust fund set up by it, in conjunction with the state government to administer compensation to those affected, has received over 600 applications from Kano citizens, all of who claim they took part in the test and ought to be compensated.

Fortunately, Pfizer claims to be in possession of files and documents containing medical records and photographs of those who took part in the test, saying the tests by doctors to determine the real patients will be at no cost to those who come to make claims.

Breakdown of the settlement requires Pfizer to pay $10 million in legal fees, $30 million to the Kano state government and $35 million to the families of children who were drafted into the trial. The settlement also includes a provision that Pfizer rebuilds Kano's Infectious Diseases Hospital (IDH), where the trial took place.

All that apart, what makes the Kano incident very curious is that the test was carried out even when animal testing had indicated that Trovan might cause significant side effects in children such as joint disease, abnormal cartilage growth, a disease resulting in bone deformation and liver damage.

In fact, the drug, which is said to belong to a powerful class of antibiotics called quinolones, in early-stage testing, had caused liver and joint damage in young rats and dogs, which should have ruled out testing in children.

Otherwise, how come that while other humanitarian organizations such as Medecins Sans Frontieres ("MSF"), also known as Doctors Without Borders, that were in Kano's IDH in respect of the outbreak, offered the sick safe and effective treatments for bacterial meningitis, Pfizer could only embark on a medical experiment involving the "new, untested and unproven" antibiotic, Trovan?

What happened in Kano in 1996, resulting in many children dying or being deformed through application of the Trovan test drugs, should never have happened and should serve as a big lesson to all other pharmaceutical companies in the world.

The crisis, no doubt, must have been a 13-year public relations nightmare and a costly legal headache for Pfizer, but it is criminal that in its haste to test Trovan, Pfizer drafted the 200 children into its clinical trial without parental consent, and intentionally low-dosed its control drug to boost the Trovan profile, same way it falsified ethics approval forms.

And this can only happen in Nigeria. Before Pfizer's 1996 trial, oral Trovan had never been tested for efficacy in children, in part because of concerns over its side effects. So how come nobody thought of, or even cared about these consequences before using them on Nigerian children?

Where were our own government and hospital officials when Pfizer was conducting the unethical and unprofessional experiments?

Source

1 comment:

Anonymous said...

Considering the illiteracy rates and poverty rates in Nigeria and Pfizer's proven track record of fraud and unethical behavior, Pfizer has once again gotten a free ride and permission to do "it" again.


Pfizer literally spends more on executive transportation every year, than they spent on the 11 deaths.