MENINGITIS, EBOLA VIRUS,EXPERIMENTAL DRUGS AND THE REPEAT OF HISTORY
A few days ago, faced with a rapidly advancing invasion of Ebola epidemic into our territory, the Nigerian Government authorities sent a request to the United States Centre for Diseases Control ( CDC) to send us some of the experimental drug that is claimed to be helpful in managing this 'latest' disease that the world has seen. Though the disease has been known in Africa for the last several years, it had not attracted serious international attention until this year. So far, the drug Zmapp has only been given to two human beings- American health workers who caught the Ebola virus while treating patients afflicted with the disease in Sierra leone. Until a week or so ago, the drug had only been tested in monkeys and had neither been approved for human subject trials nor for marketing until these Americans- good Samaritans fell sick and in the absence of any other viable alternative, in the face of imminent death, the victims agreed to try the "untested" drugs and became real " guinea pigs".
As I watched the current minister of Health, Prof Onyebuchi Chukwu declare the unfolding Ebola epidemic a national emergency while addressing the Press a few days ago, my mind went back to 1996, when Dr Ihechukwu Madubuike, the then Minster of Health addressed a World Press, calling for international help to assist the Nation deal with a rampaging and particularly vicious Meningitis epidemic that was decimating Nigerian Children. For many years, in the early months of each year, Nigeria faces a bout of Meningitis epidemic particularly in the Northern parts of Nigeria. Thousands of lives are lost each year to this disease which causes the inflammation of the lining of the brain, killing mercilessly. Up till then, the only drug available for managing the disease was chloramphenicol, a very toxic antibiotic which is hardly used all over the world now even for adults not to talk of children.This has been an annual occurrence and every year, hundreds, if not thousands of young Nigerians are killed or maimed by the disease, but in 1996, there was an exacerbation that overwhelmed the Nation, leading to the appeal to the international community to come and help us.
Pfizer International, an American Pharmaceutical company with a subsidiary operations in Nigeria hearkened to this call. In addition to bringing several medicinal products, medical equipment and consumables loaded in a chartered cargo plane which were donated to the Federal Government and the Kano State government, Pfizer decided to do a limited clinical trial on a limited number of Children using its new drug, Trovan that was undergoing clinical trials world wide. The drug was tested on 99 Children in Kano. It's efficacy and safety was measured against 101 Children who were placed on Rocephin an approved competitor antibiotic product . Out of the 99 patients who were on Trovan, the drug saved 94 patients, whereas out of the 101 patients on Rocephin 95 were saved. All the patients who completed the trial were reviewed and followed up several weeks after the end of trial and discharge from the hospital. The Children and their Parents were very grateful to Pfizer. Both the Kano and Federal governments were pleased with the goodwill shown by Pfizer. The company and its representatives were pleased that they had responded to the needs of a Nation in crisis and had helped helped save lives.
Pfizer Inc was jolted therefore to note that several months after, a Nigerian medical doctor wrote a petition against Pfizer to the Minister of Health accusing Pfizer of all sorts of things, including conducting the trials without approvals. The Minister of Health then instituted a board to investigate the accusations. The board of enquiry dismissed the accusations, noting that they were made in bad faith and for selfish reasons. The doctor was not satisfied with the verdict and then launched a full battle against Pfizer.
He carried the battle to the media and received very liberal support. When that did not yield the result, he took the campaign to the United States of America and instituted a legal action . The American Court dismissed the case. He returned to Nigeria and began to recruit support for his cause. He and his group did all within their power and influence to get the Kano and Federal governments to take over the matter and take Pfizer to court. To achieve this, he and his cohorts maintained steady adversarial media campaign against Pfizer.
Ten years after, in the middle of 2007, he succeeded in getting what he wanted. In one fell swoop, Pfizer got four suits- two from Kano state and two from the Federal government,one criminal, one civil on each side. And to booth, three top local management staff of Pfizer Nigeria who were in employment in the company when the trial was conducted in 1996 were joined in the suits in their personal capacities. The suits were well advertised in the media.
From 2007 to 2009, the matters ran in the courts, especially at the Kano Court. Pfizer maintained its innocence insisting that it did nothing wrong. It's trial drug neither killed nor maimed any child, rather, it saved life and helped Nigeria overcome a distressful epidemic.
To save its former top local management staff who had become pawns in the matter from the continuing embarrassment and pain of going to the dusty courts of Kano every month, and following the intervention of well meaning statesmen, Pfizer agreed to settle out of court. This cost Pfizer a lot money including an agreement to build an infectious diseases hospital in Kano. This twelve year ordeal of Pfizer reverberated all over the World and has changed the attitude of the global Pharmaceutical Industry towards clinical trials in Nigeria.
I have just skirted over the whole drama in this article. Some day the whole story will be fully told of how the ' Good Samaritan' became the victim largely because of the selfishness and greed of some Nigerians who believe they must profiteer even with the lives of fellow Nigerians. Nigerians would be shocked to know the full details and intrigues that happened on the Trovan case. Therefore, when I read about the request of Nigeria to the same United States to ask another Pharmaceutical Company to donate an experimental drug which had only been given to two people who are critically sick, the above story flooded into my mind. Trovan had been tested on more than 5000 patients in clinical settings before being tried on the 99 children in Nigeria and the Nigerian campaigners said it was "untested" and that the Nigerian Children were used as "guinea pigs". I wonder what they would say about Zmapp which is still in the preclinical stage, only tested in monkeys and just given to two critically ill Amricans in the case of extreme emergency and hopelessness.
The adage says "once bitten, twice shy". Little wonder I read lately, that America has declined Nigeria's request to send them the experimental drug. Would you blame them? History has a way of repeating itself.
Mazi Sam Ohuabunwa OFR