The Independent reports that drug giant Pfizer has agreed to pay a $75 million settlement nine years after Nigerian parents whose children died in a drug trial brought legal action against the company.
It’s the details of that drug trial that are of interest here:
In 1996, the company needed a human trial for what it hoped would be a pharmaceutical “blockbuster”, a broad spectrum antibiotic that could be taken in tablet form. The US-based company sent a team of its doctors into the Nigerian slum city of Kano in the midst of an appaling meningitis epidemic to perform what it calls a “humanitarian mission”. However the accusers claim it was an unlicensed medical trial on critically-ill children.
A team of Pfizer doctors reached the Nigerian camp just as the outbreak, which killed at least 11,000 people, was peaking. They set themselves up within metres of a medical station run by the aid group Médecins Sans Frontières, which was dispensing proven treatments to ease the epidemic.
From the crowd that had gathered at the Kano Infectious Diseases Hospital, 200 sick children were picked. Half were given doses of the experimental Pfizer drug called Trovan and the others were treated with a proven antibiotic from a rival company.
Eleven of the children died and many more, it is alleged, later suffered serious side-effects ranging from organ failure to brain damage. But with meningitis, cholera and measles still raging and crowds still queueing at the fence of the camp, the Pfizer team packed up after two weeks and left.
That would probably have been an end to the story if it weren’t for Pfizer employee, Juan Walterspiel. About 18 months after the medical trial he wrote a letter to the then chief executive of the company, William Steere, saying that the trial had “violated ethical rules”. Mr Walterspiel was fired a day later for reasons “unrelated” to the letter, insists Pfizer.
The company claims only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin. The pharmaceutical giant says it was the meningitis that harmed the children and not their drug trial. But did the parents know that they were offering their children up for an experimental medical trial?
“No,” Nigerian parent Malam Musa Zango said. He claims his son Sumaila, who was then 12 years old, was left deaf and mute after taking part in the trial. But Pfizer has denied this and says consent had been given by the Nigerian state and the families of those treated. It produced a letter of permission from a Kano ethics committee. The letter turned out to have been backdated and the committee set up a year after the original medical trial.
Some important things to note:
1. There’s an important distinction between a humanitarian mission and a clinical trial.
A key difference is the level of uncertainty inherent in the clinical trial — you don’t know ahead of time how well (it at all) the experimental therapy will work. You’re doing the research to build this knowledge. If you already knew the answer, then performing the clinical trial with human subjects would count as “unnecessary duplication” — crossing an ethical line by exposing the human subjects to risks that were not outweighed by a benefit (like building new knowledge).
In a humanitarian mission, presumably, you are doing everything you can to help. This would include offering the best proven treatment, or at least directing the people who need help to those who can offer the best proven treatment.
Pfizer was able to dispense Rocephin, a proven antibiotic. And, being mere meters away, the team of doctors from Pfizer was certainly able to point people toward the Médecins Sans Frontières medical aid station. That they did not gives lie to the “humanitarian mission” cover story. That the Pfizer team packed up and left while the meningitis epidemic was still raging further undermines this cover story.
2. In research with human subjects, deception is generally a very bad thing.
The recognized ethical standards for research with human subjects include respect for persons — and this includes taking steps to protect, rather than undermine, the autonomy of the human subjects.
Setting up a clinical trial that looks like a humanitarian aid station mere meters from the Médecins Sans Frontières medical aid station that is dispensing humanitarian aid seems bound to create confusion at the very least. Even if it were not clearly intended to mislead, that’s an easily foreseeable outcome.
3. In research with human subjects, informed consent is required.
Since the formulation of the Nuremberg Code, the need to obtain the consent of human subjects to participate in research has been a central tenet of the ethical standards governing research with humans. In the absence of such consent (given either by the subject or, in the case that the subject cannot render consent himself or herself, by someone with the legal authority to give such consent who is able to evaluate the subject’s best interests), a clinical trial is prima facie unethical.
The parents who brought the legal action say that they were not informed that their children were being given an experimental, rather than a proven, treatment. Pfizer says that they did obtain such consent from the families and from the Nigerian state, but the letter of permission produced to bolster this claim originated from a local ethics committee that wasn’t set up until a year after the clinical trial was conducted.
Unless the team of Pfizer doctors also had a time machine, this makes it hard to believe that they obtained the consent of human subjects or their representatives prior to the clinical trial.
4. Firing an employee who raises concerns within the company about whether clinical trials meet ethical standards does not contribute to the sense that your company cares about ethics.
Even if Juan Walterspiel’s job with Pfizer was on shaky grounds for legitimate reasons, Pfizer CEO William Steere might have done better to keep Walterspiel on while he got to the bottom of the ethical concerns Walterspiel had with the Nigerian drug trial. Taking responsibility for conducting ethical research is the kind of thing a pharmaceutical company ought to do, not only because it’s required by various regulations, but also because it is more likely to generate good will with consumers and potential subject pools for future clinical trials. The alternative — taking responsibility after the fact, when you’re caught having messed up — generates a bad reputation, and multimillion dollar settlements hurt the bottom line.
Worse, the firing of Walterspiel may set up a climate where Pfizer employees don’t believe higher-ups in the company care about the ethics (or the legalities) of research. In such a climate, if voicing your concerns within the company can get you fired, you may as well just start by bringing your concerns to those outside the company (like the government or the media) so they don’t get buried.
A note in passing: this clinical trial was apparently the inspiration for John Le Carré’s book The Constant Gardener, which was made into a movie I mentioned here some years ago. It’s kind of appalling to learn that the events depicted in the movie were based in actual misdeeds.