Washington Post kirjoittaa eilisessä lehdessä, että lääkeyritys Pfizer on suorittanut laittoman lääketestin Nigeriassa vuonna 1996. Kysymättä lupaa Nigerian hallitukselta kehitteillä olevaa lääkettä aivokalvontulehdukseen annettiin 100 lapselle ja vastasyntyneelle. Tietojen mukaan Pfizer valitsi lääketestin koeryhmäksi Kanon kaupungin kenttäsairaalan mihin oli tuotu kuolemanvakavasti aivokalvontulehdukseen sairastuneita lapsia. Julkisuuteen "vahingossa" levinneessä raportissa nigerialainen työryhmä kritisoi erityisesti tätä laitonta lääketestiä ja pitää sitä viattomien lasten hyväksikäyttönä. [The report concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants. Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis. At the time, Doctors Without Borders was dispensing approved antibiotics at the hospital. Pfizer's experiment was "an illegal trial of an unregistered drug," the Nigerian panel concluded, and a "clear case of exploitation of the ignorant."]
Pfizer puolustautuu sanomalla, että heidän lääketutkijansa lähtivät Nigeriaan filantrooppisen ("ihmisystävällisen") vastuunsa siivittäminä taistellakseen maassa riehuvaa aivokalvontulehdusepidemiaa vastaan. Tämä kuulosta aika ontolta, sillä kokeen loputtua tutkijat poistuivat maasta epidemian yhä jatkuessa. Eiköhän tässä käynyt niin, että lääkeyhtiö Pfizer huomasi tässä oivallisen tilaisuuden päästä lääkekehittelyssään kätevästi eteenpäin? [Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans. The committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while "the epidemic was still raging."]
Koesarjassa kuoli viisi lasta saatuaan koekäytössä olevaa lääkettä ja kuusi lasta kuoli saatuaan erästä toista vastaavaa lääkettä. [Five children died after being treated with the experimental antibiotic and others showed signs of arthritis, although there is no evidence the drug played a part. Six children died while taking a comparison drug.]
Kyseessä on Trovan-nimisen antibiootin kehittelytyö. Lääke sai lopullisen hyväksyntänsä aikuisille vuonna 1997 ja siitä tuli hyvin suosittu lääke. Amerikan lääkevalvontaviranomaiset (FDA) eivät koskaan myöntänyt lääkkeelle käyttölupaa lapsipotilaiden hoidossa. Vakavien sivuvaikutusten (maksavaurioita ja kuolemia) takia sen käyttöä rajoitettiin USA:ssa ja kiellettiin kokonaan Euroopassa. [The FDA never approved Trovan for use in treating American children. After being cleared for adult use in 1997, the drug quickly became one of the most prescribed antibiotics in the United States. But Trovan was later associated with reports of liver damage and deaths, leading the FDA to severely restrict its use in 1999. European regulators banned the drug.]
Jotta sekaannus olisi täydellinen, Pfizer on laatinut jälkeenpäin kaikenlaisia väärennöksiksi osoittautuneita todistuksia missä mukamas Nigerian viranomaiset hyväksyvät lääkekokeet ja lääkekokeen suorittajaksi on merkitty asiasta hyvin vähän tietävä lääkäri Abdulhamid Isa Dutse. Tästä asiasta tiesi kertoa British Medical Journal jo vuonna 2001 [The letter granting ethical approval for the Pfizer trial was submitted to the US Food and Drug Administration in 1997 to support a licence application for trovafloxacin. However, Sadiq Wali, the medical director of the Aminu Kano Teaching Hospital, told the Washington Post that the letter was false and the hospital had no ethics committee at the time of the study. Abdulhamid Isa Dutse, the doctor who oversaw the trial at the hospital, told the newspaper that it was "possible" that the approval letter was drafted up to a year after the trial. The Nigerian health minister, Tim Menakaya, has now appointed a federal investigative panel to determine whether the trial was conducted legally and if so whether it was morally right. The investigation has generated a lot of publicity in the Nigerian press. The newspaper Vanguard said: "The government has a duty to tell us whether our children were used as guinea pigs and, if so, who committed such criminality and who is liable." ]. Kieltämättä aika outo tilanne! [Pfizer had told authorities that a Nigerian doctor directed the experiment. The committee, however, found that researchers from Pfizer's U.S. office controlled the trial, and the inexperienced Kano doctor, Abdulhamid Isa Dutse, was the principal investigator "only by name." Publications listed Dutse as the lead author of articles on Trovan, but the committee found that depiction "did not sufficiently reflect his role." Dutse indicated he was kept in the dark about the experiment's results and said he did not see at least one publication until the committee showed it to him. "He was shocked that Pfizer could publish such data without showing him or intimating him with details," the report said, concluding that Dutse was "naive and exploited." The report quoted Dutse as saying that Pfizer's motive was far from philanthropic. "I have trusted people and am disappointed," Dutse told the committee. "I regret this whole exercise, I wonder why on earth I did this." Dutse admitted that he created a letter after the experiment purporting to show that the test had been approved in advance by a Nigerian hospital's ethics committee. He then backdated the letter to March 28, 1996 -- a week before Pfizer's experiment began. Pfizer used the letter as a key justification for the trial in discussions with reporters and submitted it to the FDA. U.S. regulations require the sponsors of foreign medical research seeking FDA approval to show that the tests have been reviewed in advance by an ethics committee. The Post previously reported that the hospital had no ethics committee in March 1996 and that the letterhead stationery used was not created until months after the experiment's conclusion.]
Seurataan tilanteen kehittymistä!
