For our pharmacology class, we are to debate over the legal battle between the pharmaceutical giant Pfizer and the Nigerian Government, for Pfizer’s alleged clinical trials in Nigeria during a meningitis epidemic in 1996.
Here’s what I learned about this situation in half an hour:
During a meningitis epidemic in 1996, Pfizer treated 100 Nigerian children with the antibiotic Trovan as part of its effort to determine whether the drug, which had never been tested in children, would be an effective treatment for the disease. Pfizer treated 100 other children with ceftriaxone, the gold standard for meningitis treatment, but, the suit says, at a lower-than- recommended dose. Eleven children in the trial died, and others suffered brain damage, were partly paralyzed or became deaf.
Pfizer conducted the trial at the same hospital where Doctors Without Borders […] was already providing free treatment with chloramphenicol, the cheaper antibiotic that is internationally recommended for treating bacterial meningitis.
And what has Pfizer said to this?
[…] that the number of deaths in the Nigerian Trovan trial was lower than the overall fatality rate for the meningitis epidemic and that the trial had been a philanthropic effort that benefited most of the sick children, not a self-serving effort to obtain quick clinical data, as the suit contends.
It is interesting to note that the same NYT article mentioned:
Trovan went on the market in 1998 and quickly became one of the most prescribed antibiotics in the United States, selling more than $160 million the first year. But there were soon reports of liver damage, and the F.D.A. recommended in 1999 that Trovan be used only for severely ill patients in institutional settings. Use on children has not been approved.
So does Trovan cause liver damage or brain damage?Or liver damage in adults and brain damage in children? We shall come back to this point.
The official statement from Pfizer can be found here (2006 May 8). To summarize:
[…] Pfizer conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law and Pfizer’s abiding commitment to patient safety.
Trovan was in late stage development and had been evaluated in 5,000 patients. Pfizer had scientific evidence that the medicine was effective and undertook the clinical study to determine if it would perform as well as ceftriaxone, the best drug available at the time to treat the disease.
Trovan achieved the highest survival rate (94.4%) of any treatment available at the Kano Infectious Disease Hospital, including ceftriaxone (93.8%). For patients receiving treatment at the hospital who were not in the Pfizer program, the survival rate was 89.9%. Meningococcal meningitis is a disease that, if left untreated, kills approximately four out of every 10 people who contract it.
Here’s also a summary of Pfizer’s response to Nigerian Government’s accusation, including formal challenges and statements of defense. I will look deeper into these and post a follow-up later.
Basically, Pfizer is saying that
- The Nigerian Government knew about the “clinical trial”, which isn’t a clinical trial at all, but a humanitarian attempt to cure patients with what they believe to be the best available drug – Trovan.
- They took a gamble with Nigerian children (since they don’t have clinical trial data of Trovan on children), and they won: the survival rate in patients treated with Trovan is the highest – higher than the standard drug of ceftriaxone.
Looking back at the NYT article, which stated “11 children” died, it sounded a lot worse than “the drugs have ~95% success rate”. And those 11 dead are not attributed to Trovan either; perhaps 5 of them took Trovan, and 6 of them took ceftriaxone (deduced from the relative survival rates of the two drugs).
The point about “people receiving treatment […] not in the Pfizer program, the survival rate was 89.9%”, markedly lower than either of Pfizer’s treatment groups. It seems like Pfizer’s rebuttal against the Doctors Without Borders argument: we do better than those non-profits, and the patients whom we treated were more likely to survive.
Now, a final point of debate is in the “clinical trial” aka. “humanitarian relief” itself.
Did Pfizer have good enough clinical evidence that Trovan is safe and effective in children with meningitis? If not, they were gambling with lives, and that’s inherently unethical.
Did Pfizer inform the patients and the parents of children that Trovan was not fully approved? If not, they violated laws regarding experimental drugs.