Posted inHealth / Medicine / ToMl

Body hunter: we are Guinea pigs

In 1996, Pfizer’s researchers selected 200 children at an epidemic hospital in Nigeria for an experimental drug trial. About a hundred of the kids were given an untested oral version of the antibiotic Trovan. Researchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell their parents their children were getting the experimental drug. Eleven children died. Others suffered disabling injuries including deafness, muteness, paralysis, brain damage, loss of sight, slurred speech.
The details of the case were first exposed in 2000 in an investigative series in the Washington Post. In 2007, Nigerian officials brought criminal and civil charges against Pfizer in a multi-billion-dollar lawsuit.
A State Department cable from 2009 details a meeting between Pfizer’s country manager, Enrico Liggeri, and U.S. officials in Abuja. The cable reads, “According to Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases.” A few months later, Nigeria settled with Pfizer for just $75 million.
Joe Stephens talking:
The whole experiment that Pfizer did in Nigeria goes back 14 years. It’s an amazing twisted saga, and the WikiLeaks development is just the latest twist in a just amazing story. In ’96, Pfizer was trying to get approval for a new antibiotic they thought was going to be a blockbuster drug. And as part of this, they wanted to test it on children, because you could get an extension on your patent and make billions more, potentially, by testing on children. But it’s very difficult to get children to take an experimental drug in the U.S. There’s a lot of hoops to jump through. Parents are very protective. And this was a drug that had problems with young mammals. When it was given to rabbits and dogs that were not fully developed, they became arthritic and crippled.
And so, they were trying to put together the trials, and during this time, one of the lead researchers who was in charge of this drug called Trovan saw that there was a record meningitis epidemic in Sub-Saharan Africa. They very quickly, in a matter of weeks, put together a clinical trial, loaded up their experimental drug on a DC-9, and flew it to northern Nigeria. Generally, these pediatric trials, they can take years to put together. This was done very quickly.
They arrived at one of the most disgusting, fetid hospitals in the world, according to Doctors Without Borders, in Kano. And this hospital was besieged with patients, people bringing in their children, often carried on their backs, to this epidemic camp. And Doctors Without Borders had set up there. They were using an approved drug to treat children. Pfizer came in, took over some wards, and started giving out their experimental drug. Half the children got Trovan; half got a proven drug. But they got a substandard dose. And Pfizer was there for a few weeks, tried out its drug, and flew back out.
No one really knew, other than people who were in this hospital, knew this had taken place, until we came in four years later, in 2000, and did an investigative look at this. And what we found is that Pfizer had no written, signed informed consent forms from parents, which would prove that the parents knew that their children were taking an experimental drug and had agreed to this. That’s standard procedure in the West, in the U.S. and Europe. They didn’t have these. Pfizer says, nonetheless, that parents knew what they were doing. Some people who were in the hospital at the time told us they had no idea what they were doing.
They defended their trial and said that this was an ethical trial to do, partly because they had an ethics approval from Nigeria, and they gave us a copy of this report. We later found out that this was not a real ethics approval letter, that the letterhead it was composed on didn’t exist at the time of the trial. And later, the lead investigator for Pfizer in Nigeria acknowledged to us that when there was an FDA audit in the U.S., Pfizer had called and said, “We need a copy of this ethics approval letter immediately.” He went to his office, put it together, signed it himself, backdated it a number of years, and then sent it over to Pfizer headquarters. So this has been going on for a long time.
After our stories, there was an official federal investigation in Nigeria. But it was never made public. It disappeared. And many years later, we finally got a copy of this report. It concluded that Pfizer had violated both Nigerian law and international law and was very critical. It also mentioned that members of the investigative panel had been the target of death threats during their investigation. We were told there were three copies of this report. Attorneys in the U.S. who brought a class action lawsuit said they had spent years trying to find this report that we came up with. One they tracked to a safe. And when they opened the safe, it was not there. Another was supposedly in the possession of a man who died before lawyers got to him.
After we made this report public, there was a new set of public officials in power in Nigeria, and they decided to bring criminal and civil charges against Pfizer, including homicide—both Pfizer and some current and former employees of Pfizer. The state of Kano in the northern Nigeria settled for $75 million. The federal charges, which initially were seeking $7 billion from Pfizer, just sort of evaporated. We never knew what happened to them. And now, this new revelation comes out and raises very serious questions about why those charges just evaporated.
Pfizer says they got full approval going in. There is not a lot of evidence of that. And the Nigerian government says now that’s not the case. And we’ve talked to a lot of people who think that Pfizer did not get approval and that they were coming in quickly. There was a record meningitis epidemic, and Pfizer thought this would also give them a halo effect over their drug by using it in a humanitarian fashion. Doctors Without Borders, who was operating in the hospital, saw it differently and thought they were operating humanely and Pfizer perhaps was not.
But there’s very few controls around the world. The U.S. government can’t control what goes on in Nigeria. At best, they can control what the results of the drug trials are used for back in the U.S., because this clearly was a trial that would have impacted the approval of the drug in the U.S. And by the way, the drug was ultimately approved. It was never approved for use by children in the U.S. or Europe. But then it was associated with liver toxicity and taken off the market. It’s not used at all in Europe anymore and only in very rare cases in the U.S. But it’s very hard for the U.S. to legislate what happens overseas. And when you’re in a state which doesn’t operate smoothly, a failing state, there are very few controls, so you’re left at the mercy of the local officials in place at the time. And Nigeria is a very complicated country. And at the time, in northern Nigeria, also the federal government had limited control of that region. It’s obviously a country which ranks near the bottom in various corruption indices. There have been allegations of money changing hands before this WikiLeaks allegation. So, it’s very, very difficult to police.
Musikilu Mojeed talking:
Nigerians are clearly outraged by this revelation that Pfizer hired investigators to smear the attorney general, to blackmail him to drop the federal charges. But not a lot of people are entirely surprised in Nigeria, because before the WikiLeak cable came out, our newspaper, NEXT, had exposed the mysterious disappearance of the federal charges against Pfizer. suddenly, the case just disappeared. Nobody knew how the case was withdrawn. Nigerians were not told. It was just done in secret. And our newspaper broke this story. That is, a $6 billion federal suit against Pfizer disappeared secretly, that the attorney general simply did—went into a secret deal with Pfizer and a few Nigerian lawyers without anybody knowing about it. In fact, Pfizer may have violated U.S. law, because Pfizer refused to disclose the details of that settlement, even in its filing for the quarter of 2009 to the U.S. government. So, Nigerians are clearly outraged.
And even the attorney general, the former attorney general, himself, is threatening that he might sue Pfizer for blackmailing him. But in any case, the attorney general himself is known to be terribly corrupt. So a lot of people are not surprised, because he’s know to be a corrupt man. He cannot enter the United States, because the U.S. government has barred him, has withdrawn his visa and that of his family, because he’s known to be corrupt. But a lot of people are outraged that Pfizer could go to that extent to hire an investigator to blackmail a Nigerian official.
Nigerians didn’t know, because it was just for a brief period. Pfizer just went in, briefly, and there was so much confusion in Nigeria. Nigeria needed help. There was this epidemic. The country just needed help from wherever. And Pfizer came on a humanitarian ground. Nigeria accepted. And at the time, we had military dictatorship. Things were so bad. There was no order in the country. There was no proper procedures, whenever following [inaudible] that happened at the time. So, really, at the time, Nigerians were grateful to Pfizer, and we never knew, until it broke out in the press several years later, and Nigerians were really, really outraged.
Joe Stephens article in Washington Post, Body hunters.
“By the time word of the little girl’s death reached the United States, her name had been replaced by numerals: No. 6587-0069.
“She was 10 years old and a scant 41 pounds. She lived in Nigeria, and in April 1996 she ached [from] meningitis.”
“Doctors working with Pfizer drew spinal fluid from the girl, gauged her symptoms [and] logged her as patient No. 0069 at testing site No. 6587 in experiment No. 154-149. They gave her 56 milligrams of Trovan.
“A day later, the girl’s strength was evaporating, Pfizer records show, and one of her eyes froze in place.
“On the third day, she died.
“Pfizer records are explicit. Action taken: ‘Dose continued unchanged.’ Outcome: ‘Death.’
“Nobody can know for certain if the girl would have lived had she been taken off experimental Trovan; perhaps she was beyond all hope. Yet the circumstances of her death—while taking an unapproved drug, with alternate treatments at hand, in a hurriedly established private sector experiment—suggest much larger problems.”
Discussion with Joe Stephens and Musikilu Mojeed.
Joe Stephens is a staff writer for the Washington Post. He was part of the investigative team that broke the story in 2000. He’s joining us from the offices of the Washington Post in Washington, D.C.
Musikilu Mojeed, a Nigerian journalist who has worked on this story for the NEXT newspaper in Lagos. He’s a Ford Foundation international fellow at City University of New York city.
– from democracynow.org
Please dont buy drugs from Pfizer. Have a healthy life style.
Please dont buy Pfizer stocks. Mark them killers where ever possible.

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