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Drug company 'investigated legal chief'

  1. Guttz
    The latest cables from whistle-blowing website Wikileaks include allegations against Pfizer. The world's largest pharmaceutical company is said to have hired investigators to dig up corruption allegations against Nigeria's attorney general, as leverage against a proposed legal action.

    Nigeria had charged that a Pfizer antibiotic, Trovan, which was used during a large-scale outbreak of meningitis in Kano, northern Nigeria in 1996, harmed children.

    Last year, the company paid a final settlement of $75 m to the Kano state government. However, the cable suggests that the US drug company attempted to avoid settlement payments on two other cases brought forward by the Nigerian federal government. Reporting a meeting beween Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April, 2009, it states: "According to Liggeri, Pfizer had hired investigators to uncover corruption links to attorney general Michael Aondoakaa to put pressure on him to drop the federal cases. He said Pfizer's investigators were passing this information to local media."

    Another leak provoked fears that Burma is building underground nuclear facilities. A US embassy cable quotes a Burmese officer as witnessing the help of North Korean technicians in constructing an underground facility in foothills more than 300 miles north-west of Rangoon. These reports add substance to rumours earlier this year, passed on by a miliary defector.

    Friday, 10 December 2010


  1. Guttz
    WikiLeaks cables: Pfizer 'used dirty tricks to avoid clinical trial payout'

    Cables say drug giant hired investigators to find evidence of corruption on Nigerian attorney general to persuade him to drop legal action

    [imgl=white]http://www.drugs-forum.com/forum/attachment.php?attachmentid=18341&stc=1&d=1291978569[/imgl]The world's biggest pharmaceutical company hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop legal action over a controversial drug trial involving children with meningitis, according to a leaked US embassy cable.

    Pfizer was sued by the Nigerian state and federal authorities, who claimed that children were harmed by a new antibiotic, Trovan, during the trial, which took place in the middle of a meningitis epidemic of unprecedented scale in Kano in the north of Nigeria in 1996.

    Last year, the company came to a tentative settlement with the Kano state government which was to cost it $75m.

    But the cable suggests that the US drug giant did not want to pay out to settle the two cases – one civil and one criminal – brought by the Nigerian federal government.

    The cable reports a meeting between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It states: "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. He said Pfizer's investigators were passing this information to local media."

    The cable, classified confidential by economic counsellor Robert Tansey, continues: "A series of damaging articles detailing Aondoakaa's 'alleged' corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa's cronies were pressuring him to drop the suit for fear of further negative articles."

    The release of the Pfizer cable came as:

    • The American ambassador to London denounced the leak of classified US embassy cables from around the world. In tomorrow'sGuardian Louis Susman writes: "This is not whistleblowing. There is nothing laudable about endangering innocent people. There is nothing brave about sabotaging the peaceful relations between nations on which our common security depends."

    • It emerged that Julian Assange had been transferred to the segregation unit in Wandsworth prison and had distanced WikiLeaks from cyber attacks on MasterCard, Visa, PayPal and other organisations.

    • Other newly released cables revealed that China is losing patience with the failure of the Burmese regime to reform, and disclosed US fears that Europe will cave in to Serbian pressure to partition Kosovo.

    While many thousands fell ill during the Kano epidemic, Pfizer's doctors treated 200 children, half with Trovan and half with the best meningitis drug used in the US at the time, ceftriaxone. Five children died on Trovan and six on ceftriaxone, which for the company was a good result. But later it was claimed Pfizer did not have proper consent from parents to use an experimental drug on their children and there were questions over the documentation of the trial. Trovan was licensed for adults in Europe, but later withdrawn because of fears of liver toxicity.

    The cable claims that Liggeri said Pfizer, which maintains the trial was well-conducted and any deaths were the direct result of the meningitis itself, was not happy about settling the Kano state cases, "but had come to the conclusion that the $75m figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15m a year in legal and investigative fees".

    In an earlier meeting on 2 April between two Pfizer lawyers, Joe Petrosinelli and Atiba Adams, Liggeri, the US ambassador and the economic section, it had been suggested that Pfizer owed the favourable outcome of the federal cases to former Nigerian head of state Yakubu Gowon.

    He had interceded on Pfizer's behalf with the Kano state governor, Mallam Ibrahim Shekarau – who directed that the state's settlement demand should be reduced from $150m to $75m – and with the Nigerian president. "Adams reported that Gowon met with President Yar'Adua and convinced him to drop the two federal high court cases against Pfizer," the cable says.

    But five days later Liggeri, without the lawyers present, enlarged on the covert operation against Aondoakaa.

    The cable says Liggeri went on to suggest that the lawsuits against Pfizer "were wholly political in nature".

    He alleged that Médecins sans Frontières, which was in the same hospital in Kano, "administered Trovan to other children during the 1996 meningitis epidemic and the Nigerian government has taken no action".

    MSF – which was the first to raise concerns about the trial – vehemently denies this. Jean-Hervé Bradol, former president of MSF France, said: "We have never worked with this family of antibiotic. We don't use it for meningitis. That is the reason why we were shocked to see this trial in the hospital."

    There is no suggestion that the attorney general was swayed by the pressure. However, the dropping of the federal cases provoked suspicion in Nigeria. Last month, the Nigerian newspaper Next ran a story headlined, "Aondoakaa's secret deal with Pfizer".

    The terms of the agreement that led to the withdrawal of the $6bn federal suit in October 2009 against Pfizer "remain unknown because of the nature of [the] deal brokered by … Mike Aondoakaa", it said. Pfizer and the Nigerian authorities had signed a confidentiality agreement. "The withdrawal of the case, as well as the terms of settlement, is a highly guarded secret by the parties involved in the negotiation," the article said.

    Aondoakaa expressed astonishment at the claims in the US cable when approached by the Guardian. "I'm very surprised to see I became a subject, which is very shocking to me," he said. "I was not aware of Pfizer looking into my past. For them to have done that is a very serious thing. I became a target of a multinational: you are supposed to have sympathy with me … If it is true, maybe I will take legal action."

    In a statement to the Guardian, Pfizer said: "The Trovan cases brought by both the federal government of Nigeria and Kano state were resolved in 2009 by mutual agreement. Pfizer negotiated the settlement with the federal government of Nigeria in good faith and its conduct in reaching that agreement was proper. Although Pfizer has not seen any documents from the US embassy in Nigeria regarding the federal government cases, the statements purportedly contained in such documents are completely false.

    "As previously disclosed in Pfizer's 10-Q filing in November 2009, per the agreement with the federal government, Nigeria dismissed its civil and criminal actions against the company. Pfizer denied any wrongdoing or liability in connection with the 1996 study. The company agreed to pay the legal fees and expenses incurred by the federal government associated with the Trovan litigation. Pursuant to the settlement, payment was made to the federal government's counsel of record in the case, and there was no payment made to the federal government of Nigeria itself. As is common practice, the agreement was covered by a standard confidentiality clause agreed to by both parties."

    Sarah Boseley, health editor
    Thursday 9 December 2010 21.33 GMT
  2. Guttz
    As doctors fought to save lives, Pfizer flew in drug trial team

    Amid African meningitis epidemic, 200 children were picked to test a drug. 11 died, and their families began a fight for justice

    [imgl=white]http://www.drugs-forum.com/forum/attachment.php?attachmentid=18342&stc=1&d=1291978960[/imgl]Africa's meningitis belt is used to tragedy. Annual epidemics sweep across the continent in the dry season, stopping abruptly when the rains come. In a normal year, maybe 5,000 die, mostly children and young people. But in 1996, the worst-ever African meningitis epidemic hit Nigeria's northern states. Doctors struggling to bring it under control over a period of three months recorded more than 109,000 cases of meningococcal (cerebrospinal) meningitis and 11,717 deaths.

    Kano's infectious diseases hospital, a small collection of concrete buildings inside a sandy compound, was overwhelmed, even after teams from Médecins sans Frontières arrived. They were dealing with not one but three epidemics – measles and cholera had broken out as well. Children were being seen and treated in overcrowded halls and corridors. It was chaos.

    And then a chartered DC-9 flew in from the US. On board were doctors from Pfizer, the world's biggest pharmaceutical company, and better medical equipment than the African town had ever seen. They had come to conduct a trial of an oral antibiotic called Trovan, which they wanted to test in children with meningitis against the "gold-standard" treatment of the western world, ceftriaxone. They took over part of the hospital and dosed 200 children, half with Trovan and half with ceftriaxone. And then they left, leaving behind some surplus drugs and equipment for the hospital.

    MSF's doctors were appalled at an exercise they felt was opportunistic and inappropriate. "It was not a time for a drug trial at all," says Jean Hervé Bradol, former president of MSF France, to whom the Kano teams were reporting at the time. "They were panicking in the hospital, overrun by cases on the verge of dying. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell."

    MSF had helped set international treatment standards for African meningitis epidemics – a single intra-muscular injection of oil-based chloramphenicol will save a life if a child if treated in time. And tablets, says Bradol, are not the best idea when one of the major symptoms of meningococcal meningitis is vomiting.

    MSF's doctors at the time "were too busy to have a war with Pfizer and their friends". But they were concerned. Trovan, the brand name given by Pfizer to trovafloxacin, is from the quinolone family of antibiotics. There had not been any previous suggestion, Bradol says, that it could be effective against meningitis.

    In the event, Pfizer saved 189 lives of the 200 children treated. Five died on Trovan and six on ceftriaxone. That was a death rate of 6%, which was significantly better than the 20% in some places where the epidemic was raging. In their terms, the trial was a success.

    But the drug is not to be found in African pharmacies. It was trialled on African children, but never intended for Africa. Pfizer aimed to sell it in the USA and Europe – and yet its licence was withdrawn in Europe because of concern over liver toxicity. It is not licensed anywhere for children.

    The trial did not make headlines until 2001, when doctors from MSF spoke about their concerns to the Washington Post, which was running a series on the ethics of clinical trials in the developing world. But then the accusations began. The fallout has been immense.

    At first glance, Kano, in Nigeria's remote north, is more Afghanistan than Africa. A sign warns visitors, with measured politeness, to please note that sharia law is in force and public indecency and fornication will be dealt with harshly. Notices pronounce "sharia commission" and "purity and praise be to Allah". Prayers sing from tinny radios and women walk by in headscarves.

    On the southern fringes of the Sahara desert, Kano is a frontier town in which poverty is entrenched. Traders operate from flimsy market stalls and the roads are choked with traffic spewing exhaust fumes. Hawkers try to sell masks as a defence against pollution. Rubbish is strewn in gutters and on roadsides. Poles bend under the weight of huge bunches of power cables. There are election posters, adverts for mobile phones, and a sign that says: "Dangote noodles welcomes you to Kanocapital."

    There is also a reminder of the fallout from the 1996 meningitis epidemic: billboards from the Kano state health ministry entreat: "A healthy child is a pride to society. Immunise your child now."

    Kano became famous in recent years as the state that nearly sunk the world's attempt to end polio. Its Islamic community became suspicious of the vaccine, imported from Christian countries and rumoured at one time to cause sterility. Families refused to have their children immunised. Part of that suspicion is believed to have been fuelled by the Pfizer trial.

    Mustapha Maisikeli, wearing a patterned Muslim cap and silk garments, is chairman of the Trovan Victims Forum. He rummages in a storeroom where piles of yellowing newspapers are stacked on plastic chairs. He produces some photographs of children and some documents. One is a pink card labelled "Pfizer meningitis study" that states baldly: "25lb male, 5yo, enrollment date 3 Apr 96, discharge date 6/1/96."

    Maisikeli, 63, who campaigns for families involved in Pfizer's trovafloxacin trial, lost two daughters, Fatahiyya, then 17, and Surayya, who was six. Both fell ill when meningitis swept through Kano in 1996.

    "We were all worried," said Maisikeli briskly. "I learned they were sick, and people suggested it could be meningitis. Anyone who sees his child with a fever rushes to the infectious diseases hospital. There was a queue and they selected from there – it was, 'You, follow me'.

    "We were gathered in a camp into two groups: MSF and Pfizer. When you see a European, you feel you are safe. It just so happened my children fell within Pfizer."

    He says his daughters stayed for about three days in the hospital "but fell ill again". Although meningitis usually kills rapidly, he says he holds Pfizer responsible for his daughters' deaths four months later.

    Aliyu Isa, 43, a customer services manager, lost his six-year-old son, Mahmoud. "My child had sickness as a result of meningitis," he said. "He was administered some drugs, free of charge, by the doctors. Thereafter, he had a sickness full of crying, very severe headaches and very high temperatures. He was taken in for tests and administered drugs. He was discharged. He developed uncontrollable sickness that could not be taken care of.

    "He had been treated by Pfizer. It was American experts giving a free drug. It was a very terrible experience."

    Relatives of children treated with Trovan have been trying since 2001 to bring cases against Pfizer in the US, claiming they were damaged by the drug. Three attempts to sue Pfizer in America have been dismissed and one is ongoing.

    Pfizer maintains it has done nothing wrong and that nobody was harmed in the trial. In a statement in 2007, lawyers for the drug company said that "all clinical evidence points to the fact that any deaths were the direct result of the meningitis itself.

    "The defendants always acted in the best interest of the children involved, using the best medical knowledge available. The defendants believed Trovan could save lives."

    More successful was the action brought by the Kano state government in Nigeria. Two cases in Kano, one civil and one criminal, were settled out of court in April last year for $75m (£48m). Families are to get $35m, while the rest goes to the state government and lawyers. Two boards of trustees have been set up to divide up the money.

    Two federal cases, also one civil and one criminal, were dropped by the Nigerian government in October last year. Some of the Nigerian press have demanded to know why, but no explanation has been given. Pfizer says a confidentiality agreement was signed, which is usual in such cases.

    A cable from the US embassy in Abuja in April 2009, published by the Guardian today, suggests that Pfizer hired investigators to unearth evidence of corruption against the Nigerian attorney general in order to persuade him to drop the case.

    Sarah Boseley and David Smith in Kano, Nigeria
    Thursday 9 December 2010 21.30 GMT
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