How a U.S. Court Case Explains Problems Eradicating Polio

One of the perennial problems blocking polio eradication is the persistent belief that the rounds of vaccination meant to protect children are actually a covert campaign to harm them. I’ve seen it myself, in my reporting, and studies examining the 23-year effort’s inability to get to zero describe it as well.

From the sanitized safety of the industrialized world, it’s hard to imagine how any neighborhood or tribe could hold such views. Which is why the report on Friday of news regarding a 15-year-old court case is so important. The actions that prompted the case created mistrust so long-lasting that it undermines unrelated medical campaigns, including polio, today.

As reported by Agence France Presse and the Guardian, last week four families in Kano, Nigeria received $175,000 each as compensation for the deaths of their children, who participated in a drug trial conducted by Pfizer Inc. during a meningitis epidemic in 1996. The children were four of 11 who died of meningitis during the trial and whose deaths were laid to their receiving the drug Pfizer was testing, Trovan, rather that the existing standard drug, ceftriaxone. Several dozen other children who participated in the trial suffered lasting side effects including brain damage, paralysis and deafness. The families and the Nigerian government have been pressing suits against Pfizer since 2001, and the payments made last week represent the first payouts in a $75 million settlement that Pfizer agreed to in 2009 and expanded in February this year.

The backstory: In 1996, northern Nigeria was in the midst of a massive meningitis epidemic that would grow to more than 100,000 cases. Kano, in Kano State, was the epicenter. Doctors Without Borders arrived and set up an emergency clinic in Kano State Hospital. Several weeks into the epidemic, a second team arrived and set up a second clinic at the same hospital. The second team were from Pfizer, and they were there to conduct a quickly organized randomized trial of orally administered Trovan (trovafloxacin), which had not yet been tested in children or approved in the United States. They enrolled 200 children in the trial, stayed in Kano for several weeks, and then left.

Pfizer has maintained that it had done everything correctly and with adequate permission, and that the children’s deaths or long-term symptoms were the result of their being gravely ill. (See this summary of the defense position from Pfizer’s website from 2007 and an undated factsheet.)

But in a devastating investigative project published in 2000, the Washington Post quoted 10 unaffiliated physicians that said the care of patients and the data-gathering did not match US standards.

Overlapping suits filed in several countries by the Kano families and the Nigerian government said that the trial was not approved by the government, the children’s parents were not informed of what was happening, and the children were harmed by their treatment. (Here’s a 2009 summary from The Independent and a 2010 one from the Guardian.) A Nigerian government report — written in 2001 but squelched until the Post obtained a copy in 2006 — called the Kano trial a violation of international law and a “clear case of exploitation of the ignorant.”

The ins-and-outs of the lawsuits (covered from 2007 through last week by Ed Silverman at Pharmalot) sent the Nigerian complaints all the way to the US Supreme Court and back, and resulted in Pfizer agreeing first to set up a compensation fund, and thento add to it this year in order to settle all suits. (Here’s Pfizer’s statement from then.)

So: How does this have anything to do with polio? Because Kano, where the Trovan trial was conducted, is also the center of polio vaccine refusal in Africa.

The Trovan case may not be well-known in the US (unless you read John Le Carre’s The Constant Gardener, which takes place in Kenya, not Nigeria, but is reputed to have been inspired by the drug trial), but it is very well-known in Nigeria. Last year, the Daily Champion of Lagos editorialized about it:

…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? Both the Kano and Federal Governments should, as a matter of fact, share in the blame for the pains the drug test must have caused the victims and their families. Rather than sharing in the $75m settlement, these governments should instead be co-accused for standing by and watching while these children were being used as guinea pigs.

And last summer, a Harvard PhD candidate named Shelby Grossman, who is conducting field research in Nigeria, said on her blog:

I was talking with my Hausa instructor this morning about movies we liked.  I mentioned The Constant Gardener.  She hadn’t heard of it, so I told her about the plot.  She cut me off half-way through, and said, “This happened in Kano.”

Fifteen years later, in other words, people remember that a large pharmaceutical project that was centered in Kano and that promised to help their children was not what it appeared to be. Viewed in that light, Kano’s rejection of polio vaccine, which began in 2003, was not irrational — it was reasonable.

In that year, imams in the area began preaching against the vaccine, saying that it was a plot to sicken and kill children.  Kano State is Muslim, and the president of Nigeria’s Supreme Council for Sharia Law told the BBC: “The polio immunisation vaccine was contaminated with anti-fertility drugs, contaminated with certain virus that cause HIV/AIDS, contaminated with Simian virus that are likely to cause cancers.”

Rejection of the vaccine spread so widely that polio-eradication progress in Africa not only halted, it reversed: The disease not only established itself more firmly in Kano, it leaked across borders to reinfect Benin, Botswana, Burkina Faso, Cameroon, Chad, the Central African Republic, Cote d’Ivoire, Ethiopia, Ghana, Guinea, Mali, Sudan, Togo, Yemen, and the hajj to Saudi Arabia.

Years later, Kano remains a problematic polio hot spot — and it has still not fully accepted that the polio campaign is a humanitarian effort doing good. So many children have been held out from vaccinations that when Nigeria experienced the random bad luck of a vaccine-virus reversion to wild type in 2006, it created a nationwide epidemic. Last week, Kano authorities announced they were so concerned about polio’s persistence, they will jail the parents of any child who remains unimmunized.

The lingering suspicion that polio vaccine will harm children is certainly due in part to lack of education, and to political manipulation. But it is also unquestionably due to the vivid memory of what happened the last time a foreign public health effort purported to help local children. And since the Trovan compensation has only begun to be paid, it is likely that suspicion will linger for a considerable time.

See Also:



Leave a Reply

Your email address will not be published. Required fields are marked *