Nige­rian storm rages over drug claim

Drug gi­ant Pfizer is fac­ing a le­gal bat­tle over claims African chil­dren were harmed in a clin­i­cal trial. Jonathan Clay­ton re­ports

The Weekend Australian - Travel - - Health -

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‘‘ANORAMATU Musa has lit­tle doubt why her eldest son is deaf. He is, she al­leges, a vic­tim of an il­le­gal drug trial in Nige­ria by Pfizer, the world’s largest drug com­pany. I am so bit­ter be­cause he is my eldest. All my hopes were on him. I ex­pected him to care for me when I am older,’’ said Musa, 47. ‘‘ We are poor, I have no money to look af­ter him. They [Pfizer] did this to him.’’

Nige­rian lawyers main­tain that Smai’la, 17, was one of about 200 chil­dren used as guineapigs by Pfizer in 1996 dur­ing one of the worst menin­gi­tis epi­demics to hit the coun­try. When it had run its course more than 10,000 peo­ple, many of them chil­dren, had died.

In May the Kano state Gov­ern­ment and the Nige­rian fed­eral Gov­ern­ment filed law­suits against Pfizer seek­ing nearly $A12 bil­lion in dam­ages. They al­lege that an un­tested drug was ad­min­is­tered — Trovan Floxacin, which at the time was not li­censed any­where else in the world.

The com­pany de­nies the al­le­ga­tions. ‘‘ Trovan un­ques­tion­ably saved lives and Pfizer strongly dis­agrees with any sug­ges­tion that the com­pany con­ducted its study in an in­ap­pro­pri­ate and un­eth­i­cal man­ner,’’ it said.

Trovan was ap­proved for use in the US in 1997 — but for adults, not chil­dren. It was with­drawn two years later be­cause sev­eral pa­tients died of liver prob­lems. ‘‘ It is not in use any­where to­day,’’ a com­pany spokesper­son said.

Ac­cord­ing to pa­pers sub­mit­ted by the au­thor­i­ties, the drug trial re­sulted in deaths, brain dam­age, paral­y­sis and slurred speech — all neu­ro­log­i­cal side ef­fects of the type of vir­u­lent meningo­coc­cal dis­ease that then dev­as­tated the re­gion.

One US court has dis­missed a law­suit brought by dis­abled Nige­ri­ans, but the case may be re­heard on ap­peal. Ei­ther way, the new cases would be bind­ing out­side Nige­ria be­cause of in­ter­na­tional con­ven­tions.

‘‘ A suc­cess­ful pros­e­cu­tion would af­fect Pfizer’s op­er­a­tions well be­yond Nige­ria’s borders,’’ said a se­nior com­pany lawyer in La­gos, who acts for other big in­ter­na­tional com­pa­nies op­er­at­ing in Nige­ria. ‘‘ I think they will have to settle out of court.’’

The ac­cu­sa­tions against Pfizer sur­faced seven years ago, af­ter an in-depth in­quiry by The Wash­ing­ton Post news­pa­per — doc­tors in­volved in the tri­als ques­tioned the ethics in­volved in us­ing poor coun­tries as test­ing grounds for un­ap­proved drugs.

One physi­cian sug­gested that Nige­rian doc­u­ments had been fal­si­fied; an­other said that fol­low-up mon­i­tor­ing tests on the chil­dren were in­ad­e­quate. A doc­tor in­volved in the tri­als brought a law­suit against Pfizer, but it was dropped and since then nei­ther he nor the com­pany has made fur­ther com­ment.

Smai’la, one of five chil­dren, sat next to his mother on a wooden bench inside a mod­est house on the out­skirts of the sprawl­ing north­ern Nige­rian city of Kano — home to two mil­lion mostly im­pov­er­ished peo­ple.

Obliv­i­ous to events around him, he leant his head against the bare brick wall and cast sus­pi­cious glances at yet more for­eign vis­i­tors. He lost his hear­ing af­ter tak­ing part in the trial at the lo­cal hospi­tal when he was six years old.

Now he earns his liv­ing grind­ing grain with a ma­chine do­nated by a lo­cal well­wisher, but he has run away from home on oc­ca­sion, an­gry that his mother can­not af­ford to send him to a school for deaf chil­dren.

His mother, like the par­ents of many of the other chil­dren in the trial, tells a story that raises many con­cerns over Pfizer’s be­hav­iour.

Con­trary to the com­pany’s as­ser­tion, she says that she was never told of any drug trial. She says she just took a des­per­ately sick child to hospi­tal. Lo­cal nurses or doc­tors said noth­ing to her.

The same story is told by oth­ers in Kano. A fa­ther, whose son was also in the drug trial, blames Pfizer for the re­cur­ring bouts of ill­ness that have plagued the 14-year-old boy ever since. He calls the com­pany ‘‘ vam­pires who preyed on poor Africans’’ and says that he wants com­pen­sa­tion.

The com­pany says it is not pos­si­ble to know if those who suc­cumbed would have died in any case, or if the death rates would have been much higher if the drug had not been used.

Of the 200 al­leged guinea-pigs, 11 died. Not all were given Trovan, which was ad­min­is­tered orally, as op­posed to in­jec­tions of the ap­proved and most com­monly used an­tibi­otic, cef­tri­ax­one.

Sources at the med­i­cal char­ity Medecins sans Fron­tieres (MSF), which also had a clinic at the run­down Kano hospi­tal, said that Pfizer doc­tors wanted to com­pare the two drugs. For this rea­son, they say that chil­dren who did not re­spond to the treat­ment were kept on the drugs for sake of the trial.

‘‘ In nor­mal cir­cum­stances, the first thing you do when a pa­tient does not re­spond to a drug when deal­ing with a killer like menin­gi­tis is to change the drug. They did not do this, they kept them on it,’’ an au­thor­i­ta­tive MSF source said.

He also be­lieves that dif­fer­ent amounts of the al­ter­na­tive drug were ad­min­is­tered than would have nor­mally been the case. ‘‘ Some of the things that went on do not seem to have been ap­pro­pri­ate,’’ the source said.

Fauda Has­san, a fa­ther of an­other guineapig, says that he be­lieves that the truth will never come out, partly be­cause of the com­plic­ity of cor­rupt lo­cal of­fi­cials and the fi­nan­cial power of one of the world’s lead­ing in­ter­na­tional com­pa­nies. The Times

Menin­gi­tis: Par­ents of chil­dren taken to Kano Hospi­tal claim Pfizer used their chil­dren for a drug trial that al­legedly left them deaf

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