Thursday, February 12, 2009

Nigerian Suit Against Pfizer Revived in U.S.

There is more to the Nigerian Trovan trial debate than has been mentioned in the Washington Post and similar articles. First, it is important to note that some illnesses are more common in developing countries—e.g., the “meningitis belt” in Africa, and thus studies need to be conducted in these settings, rather than in the U.S.

For example, in the 1996 meningococcal meningitis outbreak in Nigeria, ~12,000 children died over 6 months. (Three or four cases in a U.S. community would be considered an “outbreak.”) Pfizer’s study compared Ceftriaxone, given by intramuscular injections, to Trovafloxacin, given orally. Pfizer has been criticized regarding their informed consent documentation and IRB approval–not without justification, from the second-hand reports I’ve read, but…

What is rarely mentioned is that the survival rate was reportedly 94.4% Trovan vs. 93.8 Ceftriaxone. Nor is it widely known that Trovan was also being studied for meningitis in the US by well-respected pediatric infectious diseases specialists. The outcome in the US was clinical success in 79% of the Trovan patients vs. 81% in the Ceftriaxone group, and the longer-term sequelae showed no difference between the groups. (The Pediatric Infectious Disease Journal:Volume 21(1) January 2002, pp 14-22)

Nor is the value of developing oral treatments for infections generally discussed. Doctors Without Borders was treating other meningitis with intramuscular injections of Chloramphenicol—a wonderful drug that is now rarely used because it kills ~1/30,000 patients who receive it.

Multiple IM injections are painful, require sterile technique and more skilled health care workers than do oral medications. Supplies for injected drugs are more difficult and expensive to handle and administer, particularly in poorer, tropical countries.

Pfizer may not have not conducted this trial perfectly or with adequate informed consent—I don’t know, as I wasn’t there. But I do know the horror of watching young people die from meningococcal disease, and I do understand the rationale and goal of developing an oral drug for a devastating disease that episodically kills thousands of children. While I am often critical of this company, they deserve a fair trial.



  1. I enjoyed reading your article. It was quite refreshing when compared with a lot of emotional and misinformed pieces coming out of a lot of foreign media, especially in the US. What really amazed me was that most of the commentators closed their eyes to the fact that the meningitis epidemic in Nigeria killed over 12,000 kids. The jaundiced reports failed to take note of the fact that Pfizer got the written consent of the Nigerian government, the drug control agency (NAFDAC) and the Kano State government. If the defence put up by Pfizer are anything to go by, the company fully documented all the processes of the trial. Those of us who live in Nigeria and know how bad things have been in the health sector don't feel comfortable with this sordid attempt do a shakedown on a company which has partnered our country positively for 50 years. I am by no means saying that any company that does something wrong should be excused. I am saying that on balance, the toga of culpability does not fit Pfizer.

  2. Hi folks,
    Have you read today's edition of the PUNCH newspaper? It simply buttresses your contention that meningitis is endemic in parts of Northern Nigeria. Please see this report from the said PUNCH newspaper:

    26 states risk outbreak of menigitis this year —FG
    By Segun Olatunji, Kaduna
    Published: Friday, 13 Feb 2009
    The Federal Government on Thursday in Kaduna raised the alarm of an impending outbreak of the deadly cerebro spinal meningitis in about 26 states of the federation this year.
    The Minister of State for Health, Dr. Aliyu Idi Hong, disclosed this at an advocacy and sensitisation meeting of the commissioners for health from the 26 high risk CSM states on enhanced meningitis control, epidemic preparedness and response.
    He said that the CSM epidemic, which occurred every 10 years mainly in the 19 Northern states, had now spread into about seven other states in the southern part of the country.
    The southern states standing the risk of the epidemic include Oyo, Ebonyi, Enugu, Imo, Anambra and Cross River State.
    According to Hong, a worse outbreak of the disease, which last broke out in the country in 1996 and resulted in a high casualty figure, was being expected since 2007.
    He added that there were clear indications that the nation was “sitting on the keg of gunpowder waiting to explode.”
    The minister, however, said that the Federal Government had already taken proactive measures to check the outbreak and spread of the epidemic through the procurement of 1.6million doses of drugs.
    He added that the Federal Ministry of Health had also set aside about N300m for other drugs to manage the situation.
    Hong said, “Every functionary must start to prepare for the emergencies towards addressing this issue.
    “You don’t need to be told. It happened in 1986; it came around in 1996 and we have been expecting it since 2007 and we are seeing the graph going up.
    “We are now at the verge of a major epidemic. So, I see no reason why we shouldn’t have started working towards arresting this epidemic in good time.
    The quantity is small but the beauty of avoiding this epidemic is that we just need a very small population to provide immunity for the entire population.
    “So we are hoping because there is a global scarcity of supply of this vaccine. We were made to understand that the accredited manufacturers of this drug will only manufacture about six million doses in a year.
    “So, we are challenged. We are the highest demander of this supply. So, we are ordering about 1.6million doses and in the next one week it will be available and it will be sent to the places that have the highest risk so that we will try and build up the hard immunity.”
    The minister, therefore, appealed to state governments to support their state ministries of health to effectively check the impending outbreak.
    Earlier, the state commissioners for health in their statement of commitment towards combating the CSM read by the Anambra State Commissioner for Health, Prof. Amobi Ilika, committed themselves to providing the required leadership to deal with the looming epidemic.
    The commissioners also said that they would ensure that public health and other laboratories were involved in the diagnosis and management of the disease.