(Round 1 is here)
So, this debate is looming close, and I’m sure my classmates have all been busily scrambling to finish the papers. I think it might be a good idea for me to actually start something productive too.
I’m on the team arguing for Pfizer, so I will go ahead and take that position. (With Pfizer’s articulate, persuasive, lawyer-crafted statements, this position isn’t hard to take at all.)
What’s the fuzz?
Frankly, people hate big drug companies. Especially when they go into poor nations like Nigeria during an epidemic, grab 200 kids and give them experimental drugs, and leave. It sounds really bad when you say it like that.
The meningitis epidemic of 1996
To quote from Pfizer (Trovan fact sheet):
The first half of 1996 marked the beginning of the most serious cerebral spinal meningitis epidemic ever recorded in Nigeria. The epidemic took almost 12,000 lives over a six-month period, affected close to 110,000 people and constituted a severe public health crisis for the government of Nigeria. Amongst all recorded cases, the fatality rate was as high as 20% in the first weeks, and eventually decreased to 10.7%.
In short, a serious big deal.
What did Pfizer do?
Pfizer went to the Kano Infectious Disease Hospital in Nigeria during the epidemic, and treated approximately 200 children. 100 of them received Trovan, Pfizer’s new antibiotic in clinical trials at that time, and the other 100 received Ceftriaxone.
The results: Trovan saved lives. The 100 children receiving Trovan had a 94.4% survival rate, and those who received Ceftriaxone had a 93.8% survival rate. The overall survival rate in Nigeria was less than 90%.
Did they gamble with lives?
Development of new drugs is always a gamble with lives. FDA’s approval for Trovan to enter Phase III clinical trials shows that Pfizer has demonstrated sufficient evidence for the efficacy and safety of the drug in Phase I and II. Effectively, drugs entering Phase III are gambles that are deemed acceptable. If you have problems with that, your problems are with the drug approval process, not Pfizer.
Sure, maybe Pfizer obtained American approval. How about Nigerian?
Well, the Nigerian government has been known for its inability to provide an adequate health care system. To quote from a HIV/AIDS prevention organization: “Over the last two decades, Nigeria’s healthcare care system has deteriorated because of political instability, corruption and a mismanaged economy. Large parts of the country lack even basic healthcare provision.” (AVERT, Nov 2007).
There isn’t even a law or regulation governing clinical trials or investigative study in the country (Trovan Statement of Defense Summary), so Pfizer did not violate Nigerian laws by conducting the clinical trials. However, Pfizer did obtain “numerous other forms of approval by local physicians and government officials authorizing the study to go forward”.
[[may be continued depending on audience response :)]]