Under 15 U.S. Code § 3710c, federal researchers, whose work was patented and commercialized, receive royalties at the rate of at least 15% of what the US government receives from the licensees, capped at $150,000 per person, per year. NIH and CDC pay their scientists 25% (on amounts over $50,000). These royalties are paid even after the person leaves the government employment and continue after his or her death.
NIH, NIAID, or CDC researcher who contributed to the development of a novel drug or therapy, and was named as one of the inventors on a commercialized patent, may be entitled to $3 million in royalties over the 20-year lifespan of the patent.
Federal agencies and laboratories, including NIH, NIAID, and CDC, are also encouraged to spread collected royalties among employees “who are not an inventor of such inventions but who substantially increased the technical value of such inventions”.
These royalties directly conflict with the main purposes of the National Institutes of Health and federal medical labs:
– to have the ability and independence to honestly evaluate drugs developed by private pharma companies
– to undertake research and development for which the private sector has no incentives.
NIH Scientists Caught Concealing Millions in Royalties for Experimental Treatments
The Associated Press has uncovered evidence of scientists and administrators at the National Institutes of Health flagrantly disregarding ethical and legal requirements of financial disclosure: “In all, 916 current and former NIH researchers are receiving royalty payments for drugs and other inventions they developed while working for the government.”
According to records obtained by the AP, among the 51 NIH scientists currently involved in testing products for which they secretly receive royalties, are Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases and his deputy, Dr. H. Clifford Lane who “have received tens of thousands of dollars in royalties for an experimental AIDS treatment they invented [interleukin-2]. At the same time, their office has spent millions in tax dollars to test the treatment on patients across the globe.”
According to the AP, the government has licensed the commercial rights to interleukin-2 to Chiron Corp: “Fauci’s division subsequently has spent $36 million in taxpayer money testing the treatment on patients in one experiment alone. Known as the Esprit experiment, it is one of the largest AIDS research projects in NIH history, testing interleukin-2 on patients at more than 200 sites in 18 countries over the last five years.”
Five years ago Donna Shalala, then Secretary of the Health and Human Services, issued federal requirements (2000) of financial disclosure requiring NIH scientists to disclose their financial interest in experimental treatments on informed consent documents reviewed by patients being recruited as test subjects. According to the Associated Press, NIH administrators did not even consider implementing the 5 year old federal requirement until AP filed a Freedom of Information request last week: “Quite frankly, we should have done it more quickly…”
Scientists at the nation’s premier research centers who violate ethical and legal requirements and use underhanded recruitment tactics, pose a very real and present threat to public safety: “hundreds, perhaps thousands, of patients in NIH experiments made decisions to participate in experiments that often carry risks without full knowledge about the researchers’ financial interests.”
The scope of ethical / legal violations and corrupt human recruitment practices by researchers at America’s premier medical research institutions is reaching the proportions of a tzunami. Self-regulation and peer review have proven about as reliable at ensuring ethical and scientific integrity as expecting the Mafia to vouch for the honesty of one of its own…
It will take more than pledges and promises by the director of NIH – it will take more than TALK about “transparency” to restore moral integrity. It will take a law accompanied by specified penalties to fit the crime – like the Sarbanes Oxley law. And most important, it will take an external enforcement mechanism to keep scientists honest. Say, a “corrupt science practice” division at the Department of Justice. It will also require effective whistleblower protection laws.
Two of the U.S. government’s premier infectious disease researchers are collecting royalties on an AIDS treatment they’re testing on patients using taxpayer money. But patients weren’t told on their consent forms about the financial connection.
Drs. Anthony Fauci and H. Clifford Lane, who helped invent the experimental interleukin-2 treatment being tested around the globe, even tried to alert patients about their royalties but were rebuffed by their own agency.
They’re hardly alone.
More than 900 current and former scientists at the National Institutes of Health legally collected $8.9 million in such royalties last year for drugs and inventions they discovered while working for the government, according to information obtained by The Associated Press.
But until last week, none was required to tell patients about their royalties despite the government’s promise in May 2000 that all scientists’ financial stakes would be disclosed to patients.
That’s because NIH didn’t get around to enacting a policy requiring the disclosure until after AP requested the royalty payments and disclosure policies under the Freedom of Information Act in December. The policy was formally distributed last week.
The nearly five-year delay means hundreds, perhaps thousands, of patients in NIH experiments made decisions to participate in experiments that often carry risks without full knowledge about the researchers’ financial interests.
“Quite frankly, we should have done it more quickly. But as soon as Director (Elias A.) Zerhouni found out about it, he ordered it done immediately,” NIH spokesman John Burklow said.
Ethics experts said the delay ran contrary to a basic premise of government ethics — open and full disclosure.
“It’s hard for patients to make an informed decision when they don’t have all the information,” said Bill Allison of the Center for Public Integrity, which monitors the ethics of government employees.
“When a doctor says, ‘Here, try this experiment, it is safe, or it will help,’ and the patient isn’t aware he has a financial interest in the outcome of that treatment, it in essence is taking advantage of someone by not letting them have all the information,” Allison said.
In all, 916 current and former NIH researchers are receiving royalty payments for drugs and other inventions they developed while working for the government. They can collect up to $150,000 each a year, but the average is about $9,700, officials said.
In 2004, these researchers collected a total of $8.9 million. Only a dozen received the legal maximum.
The government owns the patents and the scientists are listed as inventors so they can share in licensing deals struck with private manufacturers. In addition to the inventors’ take, the government received $55.9 million in royalties for the same inventions and put that money back into research.
Fauci and Lane have each received $45,072.82 in royalties since 1997 when the government licensed the treatment they invented to drug maker Chiron Corp.
Both doctors said they, too, were concerned about the appearance of a conflict of interest since the NIH division they oversee has been spending $36 million to test interleukin-2 on patients.
As a result, they took steps on their own to address the problem while NIH delayed in enacting a policy. For instance, the National Cancer Institute was brought in to independently review and approve the research in advance.
And Fauci tried to give back the royalty money he got from the interleukin-2 treatment and to disclose the payments on his public ethics forms. Both times he was rebuffed by his own agency, which declared he could do neither under the law.
So his only option was to donate all the money he has received since 1997 to charity. “I’m going to give every penny of it to charity … no matter what the yearly amount is,” Fauci said in an interview.
Lane is keeping his royalties, but said he pressed for years for a disclosure policy and occasionally gave interleukin-2 patients scientific journal articles that mentioned he was the inventor on the treatment’s patent.
“I believe patients should know everything that might influence their desire to be participants in research,” Lane said.
Both acknowledged they were unwilling to tell interleukin-2 patients about the royalties on consent forms until NIH developed its policy. Both will do so from now on.
“We were reluctant to make a formal policy until the broad policy came down from the department and NIH,” Fauci explained.
Their case illustrates the gulf between what the government promised nearly five years ago in the midst of controversy and what actually has been done.
Then-Health and Human Services Secretary Donna Shalala pledged in May 2000 that the government would develop policies to require “that any researchers’ financial interest in a clinical trial be disclosed to potential participants.”
Congress, concerned by reports of conflicts of interest and researchers’ conduct in several high-profile experiments, was told the changes would happen. The government first published guidance for the disclosure in January 2001.
Current HHS Secretary Tommy Thompson issued new guidance in May 2004 that again clearly cited “compensation that may be affected by the study outcome” and “proprietary interests in the products, including patents, trademarks, copyrights or licensing arrangements.”
NIH, however, didn’t order the disclosure until last week’s policy.
In 2000 the Washington Post published a major exposé accusing Pfizer of testing a dangerous new antibiotic called Trovan on children in Nigeria without receiving proper consent from their parents. The experiment occurred during a 1996 meningitis epidemic in the country. In 2001 Pfizer was sued in U.S. federal court by thirty Nigerian families, who accused the company of using their children as human guinea pigs.
The trials led to the deaths of 11 children. Dozens more were left disabled.Pfizer’s Unapproved Clinical Trial The unauthorized trial involved tests on 200 children with Pfizer’s antibiotic Trovan. Source: BBC News
In 2011, Pfizer paid $700,000 to four families who lost children during the Trovan trials.
In addition, the company set up a $35 million fund for those affected by Trovan. Pfizer also agreed to sponsor health projects in Kano, Nigeria.
The question that boggled many analysts: How din Pfizer manage to settle so low, after Kano initially filed for $7BILLION damages?
Timeline of the legal case
2006: a panel of Nigerian medical experts concluded that Pfizer had violated international law.
“After more than a decade of silence, the Nigerian government has decided to sue Pfizer, seeking $7bn (£3.5bn) in damages for the families of children who allegedly died or suffered side-effects in the experiment. Kano State government has also filed separate charges against Pfizer. But Mr Sani says compensation will not be enough. “In addition to the compensation, they should be killed like the children they have killed,” he says. The Pfizer experiment was cited by many as a reason for the mass rejection of polio vaccinations in many parts of northern Nigeria in recent years. Some local Islamic preachers said there was a western plot to sterilise Muslim women. After several tests were carried out to proving the vaccine’s safety, the programme has now been resumed. Whether the families ever receive compensation, it will never be enough to bring back Anas’s lost dreams of becoming a soldier.” – BBC
At the end of January 2009, a New York appeal court ruled Mr Etigwe and Mr Altschuler’s case could be heard in the US. The Connecticut attorney says it could still go ahead. “Our case is firmly embedded in the US … so a Nigerian settlement does not foreclose our case. But this is very good news. I’m glad we remained the constant gardener and could see this come to fruition.”
Eleven of the children died and many more, it is alleged, later suffered serious side-effects ranging from organ failure to brain damage. But with meningitis, cholera and measles still raging and crowds still queueing at the fence of the camp, the Pfizer team packed up after two weeks and left.
That would probably have been an end to the story if it weren’t for Pfizer employee, Juan Walterspiel, the Independent writes in 2014. ” About 18 months after the medical trial he wrote a letter to the then chief executive of the company, William Steere, saying that the trial had “violated ethical rules”. Mr Walterspiel was fired a day later for reasons “unrelated” to the letter, insists Pfizer.
2014: Pfizer to pay only $163.50m after deaths of Nigerian children in drug trial experiment!
Out of court settlement in the case inspired ‘The Constant Gardener” movie.
The company claims only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin. The pharmaceutical giant says it was the meningitis that harmed the children and not their drug trial. But did the parents know that they were offering their children up for an experimental medical trial?
“No,” Nigerian parent Malam Musa Zango said. He claims his son Sumaila, who was then 12 years old, was left deaf and mute after taking part in the trial. But Pfizer has denied this and says consent had been given by the Nigerian state and the families of those treated. It produced a letter of permission from a Kano ethics committee. The letter turned out to have been backdated and the committee set up a year after the original medical trial.
At stake at one point in 2013 was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. “There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano,” Mr Etigwe said. “The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer.”
Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.
It appears that Pfizer has finally ended the public relations nightmare with Friday’s settlement. But the Trovan battle may not be over yet.
2015: Nigerian govt withdraws civil lawsuit in preparation for new case against Pfizer. New case never followed.
Reuters: Nigerian government lawyers have withdrawn a 7 (b) billion US dollar civil lawsuit against US drugmaker Pfizer on Friday in preparation for filing a new case, with new material they believe will strengthen their case. The criminal case, is one of three currently being brought in Nigeria against the company. The government has accused Pfizer, the world’s largest pharmaceutical company, of taking advantage of a 1996 meningitis epidemic to test an experimental drug without authorisation or full understanding of the families involved – allegedly contributing to the deaths of some of the children and making others sick. Pfizer denies wrongdoing. The civil case is in addition to a federal criminal case and separate from civil and criminal cases launched at the state level in the northern state of Kano. All the cases stem from the same mid-1990s drug study. Pfizer treated 100 meningitis-infected children with an experimental antibiotic, Trovan. Another 100 children, who were control patients in the study, received an approved antibiotic, ceftriaxone – but the dose was lower than recommended, the families’ lawyers alleged. Up to 11 children in the study died, while others suffered physical disabilities and brain damage. Pfizer always insisted its records show none of the deaths was linked to Trovan or substandard treatment. Barrister Abdulateff Thomas said that he did not accept any of the company’s excuses that the studies were conducted through a deal with the Nigerian government. “If there was any deal at all it was made by an individual against the interest of the government, against the interest of a nation,” he said. “Could they do that deal in America? Can they do it in the UK? Or in any of the European countries? No,” he added. Speaking before the latest development, he added that he did not believe that Pfizer would suffer any consequences as a result of the – now withdrawn – lawsuit. “Nothing is going to happen to Pfizer, if anyone tells you otherwise. Pfizer is going to remain strong, he said. Authorities in Kano state are blaming the Pfizer controversy for widespread suspicion of government public health policies, particularly the global effort to vaccinate children against polio. Islamic leaders in largely Muslim Kano had seized on the Pfizer controversy as evidence of a US-led conspiracy. Vaccination programmes restarted in Nigeria in 2004, after an 11-month boycott.
So we have over a decade of legal battles in which Pfizer saves about $7billion in penalties. As spectacular as it is mysterious. No one has ever revealed an official explanation that satisfies that kind of success, you would expect some solid steel evidence that crushed the cases and the demands from the plaintiffs, but that is unheard of.
The answer might be hidden is some classified U.S. State Department cables made public in 2010 by Wikileaks, which indicated that Pfizer had hired investigators to dig up dirt on Nigeria’s former attorney general as a way to get leverage in one of the remaining cases. Pfizer had to apologize over the revelation in the cables that it had falsely claimed that the group Doctors Without Borders was also dispensing Trovan during the Nigerian meningitis epidemic. And by doing so, validated the cables.
A Pfizer representative in a phone interview with Washington Post declined to discuss specifics of the cable or Liggeri’s alleged comments. In its written statement last week, Pfizer said it negotiated the confidential settlement with the federal government “in good faith and its conduct in reaching that agreement was proper.” Pfizer said it had agreed to pay the legal fees and expenses incurred by the federal government in the litigation and no payment was made to the federal government of Nigeria itself.
According to the cable, Liggeri also told U.S. officials that the lawsuits were “wholly political in nature,” and that the humanitarian group Doctors Without Borders also gave children Trovan. Officials with the organization said that is not the case, and other records suggest that only Pfizer would have had access to Trovan at the time.
Doctors Without Borders published this response in 2011: “Among the US government diplomatic cables recently published by the Wikileaks website were details of a meeting between an official from the pharmaceutical company, Pfizer, and US Embassy officials in Nigeria in April 2009.
At the time of the meeting, Pfizer was in the midst of a legal battle with Nigerian government officials regarding a medically unethical antibiotic clinical trial in children. The clinical trial took place in Kano State in 1996 during a massive meningitis outbreak.
Pfizer carried out the trial of the oral antibiotic trovafloxacin, branded Trovan, even though there had not been any previous medical evidence that it could be effective against meningitis. The Pfizer researchers conducted the trial in Kano State Hospital, where a Doctors Without Borders/Médecins Sans Frontières (MSF) team was treating children using a preferred and clinically approved antibiotic regimen for bacterial meningitis.
A US$75 million settlement with the State of Kano was reached July 30, 2009. Other cases are still pending before the US courts and the Nigerian federal government continues to pursue legal claims against Pfizer.
It is against this backdrop that Pfizer falsely accused MSF in the US diplomatic cables of using Trovan. Documented evidence has shown that these accusations are patently false. MSF did not, at any time, administer Trovan to patients. Litigation connected to this case and comprehensive investigative reports on the matter suggest that Pfizer’s attempts to rewrite history are intended to deflect responsibility for the company’s actions.
MSF was not working in the same part of the hospital in Kano State as Pfizer clinical researchers, and MSF staff had no connection to Pfizer. When MSF staff became aware of what Pfizer was doing, they were appalled at the practices of the company?s team. MSF personnel on the ground communicated their concerns to both Pfizer and the local authorities.
“It was not a time for a drug trial,” 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 critically ill patients. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell.”
Pfizer officials have made no attempt to clear the record as of yet and retract these unsubstantiated claims against MSF. A handful of internet reports have adopted the version of events proffered by the Pfizer official.
An exhaustive Washington Post investigation, drawing on extensive background information and interviews provided by MSF staff, published on December 17, 2000, makes clear the distinction between Pfizer?s activities and the work of MSF during the meningitis outbreak:
‘Behind a gate besieged by suffering crowds stood two very different clinics. A humanitarian charity, Doctors Without Borders, had erected a treatment center solely in an effort to save lives. Researchers for Pfizer Inc., a huge American drug company, had set up a second center. They were using Nigeria’s meningitis epidemic to conduct experiments on children with what Pfizer believed was a promising new antibiotic?a drug not yet approved in the United States.’
The article later triggered the various legal proceeding taken by the victims and Nigerian authorities against Pfizer.
With proven treatments at hand, Pfizer instead chose to carry out tests for an unproven drug on children whose lives hung in the balance. ‘The situation called for using treatment protocols known to be effective rather than carrying out clinical trials on a new antibiotic, with uncertain results,’ said Dr. Bradol.”
BBC reported it too at the time (2010):
“According to a US cable released by WikiLeaks, Pfizer wanted to “put pressure” on Michael Aondoakaa. He was heading a lawsuit against the company over a 1996 drug trial during a meningitis epidemic. The trial allegedly led to the deaths of 11 children – charges Pfizer denies. Pfizer reached a $75m settlement last year with Nigeria’s Kano government over the case, which also allegedly left dozens of children disabled.
The cable quoted conversations said to have taken place between US embassy staff and Pfizer’s head in Nigeria, Enrico Liggeri. It referred to a meeting between Mr Liggeri and US officials on 9 April 2009.
“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,” the cable released by the whistle-blowing website WikiLeaks said. “He said Pfizer’s investigators were passing this information to local media.”
Mr Aondoakaa was removed from the position of justice minister in February this year by Nigerian President Goodluck Jonathan.”
Thing is no one has ever proven a Wikilieaks cable to be fake, definitely not this one.
Another good report on the cables I found in mainstream-media comes from the Atlantic (2010):
“In 2000, following the Post revelations, a cry for justice in the Nigerian media triggered street protests and an investigation by Nigeria’s health ministry, whose report on the incident went missing until 2006, when a leaked version revealed that the health officials had reached more or less the same verdict as the fired Pfizer expert: The experiment was “an illegal trial of an unregistered drug,” a “clear case of exploitation of the ignorant,” and a violation of Nigerian and international law.
These disclosures prompted a raft of civil and criminal lawsuits in Kano State Court on behalf of the families and in Federal High Court on behalf of the nation itself, as it were. But Pfizer kept the suits tangled up in proceedings to postpone any settlement.
A State Department cable dated April 20, 2009 and released by WikiLeaks, however, suggests that Pfizer’s legal strategy was not simply to delay–it was also to blackmail. Written by an economic counselor at the US embassy in Abuja, Nigeria, the cable reports minutes of meetings during which Pfizer representatives informed the U.S. ambassador that the firm had agreed to settle the Kano State suit for $75 million, mere pocket change for the pharma giant. The ambassador was told that Pfizer “was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15 million a year in legal and investigative fees.”
It was how Pfizer deployed these fees that dropped a bombshell:
According to [Pfizer country manager Enrico] 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, XXXXXXXXXXXX. 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.
Blessed with immense reserves of oil, Nigeria, like many oil-rich developing nations, has in turn been cursed with extravagant corruption. Aondoakaa was among those caught up in it. The cable does not mention Pfizer’s settlement of the $6 billion federal lawsuit, which was signed in secret by lawyers from Pfizer and the Aondoakaa-led Nigerian ministry of justice in October 2009. With the settlement’s terms under wraps, how much Pfizer paid and to whom remains a mystery.
In February 2010, Aondoakaa was booted from the government over charges of corruption. Pfizer denies the version of events reported by the U.S. Department of State official. “Any notion that the company hired investigators in connection to the former attorney general is simply preposterous,” Christopher Loder, a Pfizer spokesman, toldThe New York Times.
When I emailed Loder asking for comment about the allegations in the WikiLeaks cables, he repeated his statement to the Times verbatim, adding that the cases had been “resolved in 2009 by mutual agreement” and that Pfizer’s conduct was “proper.”
The 1996 Trovan tragedy has cast a long shadow. In 2003, the parents of Kano State boycotted a U.S.-made polio vaccine, threatening to single-handedly short-circuit the global initiative to eradicate the disease. These parents bore the legacy of the Trovan trial and the ensuing years of failed and foiled litigation. Suspicion and cynicism of Western motives ran so deep that they accepted their local clerics’ warnings that the polio vaccine was a plot by Christians to sterilize their daughters, relenting only when health officials switched to a vaccine manufacturer based in Indonesia, a Muslim nation.
Despite all this, Pfizer apparently perceives itself as the real victim. As detailed in the leaked cable, Liggeri portrayed Pfizer to the ambassador as entirely the injured party, dismissing the lawsuits as “wholly political in nature” and asserting that during the meningitis outbreak in 1996, MSF also administered Trovan to children. (When asked for comment by the Guardian, 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.”) Liggeri warned darkly that the lawsuit against Pfizer had so chilled the entire pharmaceutical industry that “when another outbreak occurs no company will come to Nigeria’s aid.” Whether or not that’s true, it’s not clear that Nigerians would want Pfizer’s help after all.”
However, it took some real alternative independent media to reveal the gravity of the situation, in 2010, when the Democracy Now! news outlet hosted an Washington Post reporter involved in the case and a Nigerian journalist. Dhe deadliest details came together:
“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.” – Joe Stephens is a staff writer for the Washington Post. He was part of the investigative team that broke the story in 2000
Musikilu Mojeed, a Nigerian journalist who has worked on this story for the NEXT newspaper in Lagos, commented the following: “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 WikiLeaks cable came out, our newspaper, NEXT, had exposed the mysterious disappearance of the federal charges against Pfizer. You know, 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.”
Evidences of various forms of wrong-doing on the Pfizer side kept appearing the following years, see this 2011 CBS news piece:
Pfizer Bribed Nigerian Officials in Fatal Drug Trial, Ex-Employee Claims
“A former Pfizer (PFE) employee’s letter to a federal judge alleging that the company put a courier on a KLM flight to Nigeria carrying bribes for local officials is a classic example of how hard it is to get away with corporate skullduggery: The letter cites 40 Pfizer executives, FDA officials and other witnesses who allegedly have inside knowledge of the scandal — not very secret for a secret conspiracy.(…)
The letter was written by Dr. Juan Walterspiel, who in 1996 was a pediatric research physician in Pfizer’s Groton, Conn., facility. He worked on the Trovan trials, but he objected to the testing method being used. Pfizer dismissed him in 1998. His letter claims that:
Pfizer paid a bribe to continue the study of Trovan.
Pfizer did not get informed consent from parents of children in the test.
Pfizer gave fake ethics documents backing the test to the FDA.
Corners were cut because “Speed was of the essence and stock options and bonuses at stake.” Pfizer ignored Trovan’s poential reaction with antacids, which are often given to patients who have had surgery.
The FDA started but mysteriously called off an investigation into the scandal.
One patient in the Trovan arm of the experiment died without being taken off Torvan or given medical care. Normally, if patients react badly to experimental drugs researchers take them off the therapy and give them medical care.
Pfizer has photographs of the members of its Kano team.
Dr. Juan Walterspiel’s employment with Pfizer was terminated in 1998 for legitimate and proper reasons. Dr. Walterspiel did not travel to Nigeria to participate in the 1996 Trovan clinical trial and thus has no direct or first-hand knowledge of the conduct of the clinical trial. Dr. Walterspiel made these similar allegations over 10 years ago, and has repeated them from time to time since then. Pfizer investigated the allegations and found that they were not supported by the facts.”
Walterspiel’s letter was based on an affidavit filed in the case in the early 2000s. At the time, much of the case was under seal and documents were not electronically filed, so Walterspeil’s allegations went largely unnoticed beyond the lawyers who saw them. Walterspiel then wrote to former Pfizer CEO Jeff Kindler in 2007, repeating his claims. He sent a copy of that letter it to Judge William Pauley on Jan. 28, 2011, who entered it onto the record a few days ago.
The letter does not name names. Instead, Walterspeil uses numbers to stand in for the identities of the people he links to the Trovan trial. Three of them knew that Pfizer had sent a cash courier to some Nigerian officials who “needed to be paid off” before the trial could continue. Pfizer had not obtained the proper ethics committee approvals before the test began, Walterspeigel claims. (Research on human subjects usually requires approval of an independent institutional review board before it can start.) So the paperwork was faked. The FDA began investigating the Trovan trial but the probe was suddenly ended. The older ruling supplies some of the names behind the numbers. Local sources also accused corruption between the corporation and the government.”
In addition to blaming Pfizer, many local media commentators also lamented what they saw as a corrupt Nigerian administration that had rubber-stamped the trial without due diligence. “The propensity for corrupt practices on the part of a few venal Nigerians has apparently permitted our people to be used as a laboratory for the unregulated testing of a new drug with obviously bad consequences thereof,” read a Feb. 8 editorial in Lagos’s independent weekly Tempo.
Meanwhile, the residents of Kano have been left with a legacy of fear. The News, a weekly magazine from Lagos, reported on Jan. 29, 2001 that people in the district are refusing new immunizations for CSM, cholera, and measles. “The bature (white men) will kill us again if we allow them to give us…tablets and injections,” they told the magazine.
According to John Murphy’s report for the Baltimore Sun, the Trovan trial may have left some Nigerians distrustful of Western interventions: “Some of Kano’s fears of the vaccine stem from its experience with the U.S. pharmaceutical giant Pfizer Inc.”
“The country’s health authorities say that the Pfizer controversy is partly responsible for many families in northern Nigeria refusing to allow their children to be vaccinated against polio. That in turn has been blamed for an outbreak that spread across parts of Africa. The Kano authorities also refused to distribute the polio vaccine.” – The Guardian 2007
2. Meet Nigerian born Dr Onyeama Ogbuagu, who is allegedly at the core of developing the Pfizer vaccine. He is one of the twin sons of Prof. Chibuzo Ogbuagu. His parents had the twins in New Haven CT when they went for their doctoral programs at Yale. The Ogbuagu’s returned to Nigeria where Onyeama studied medicine and then returned to the US and Yale.
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! Articles can always be subject of later editing as a way of perfecting them
Need an experienced Romanian journalist to guide you through the local specifics of the Biden – Romania connection? It’s your lucky day: suffice to say that, as a mainstream news journalist, I shook hands with all Romanian presidents since the 1989 coup against Ceausescu.
LATER UPDATES ABOUT PREVIOUSLY UNREVEALED BIDEN BUSINESS IN ROMANIA AT THE END OF THIS EXPOSE!
LOCAL CONTEXT EXPLAINED LIKE NO OFFICIAL MEDIA WOULD DARE
Ukraine are two separate nodes in geopolitics. Ukraine is a historical Motherland for the Khazarian Jewish mafia, while Romania is both a treasure island for its resources and a historical confluence point for many cultures, tribes and interests. They have a lot to share, and usually anyone who dominates the market in one tries to expand next to the other, NATO and Obama paved the way too. But Romania is perceived as “a Latin island in a Slavic sea”. The neighboring Russia formed when the Russ tribes took control over the Moscow area from the Khazars, not long after many of them converted to Judaism, but most Khazars never left that land and the two populations learned to co-exist.
Joe Biden has been very active in Romania since the Obama presidency.
“Romania was by then a familiar place to the Biden family. A close friend and former staffer of Joe Biden, Mark Gitenstein, held the position of U.S. ambassador to Romania from August 2009 to December 2012. In March 2012, Hunter’s brother, Beau, was asked to do the ribbon-cutting at the new U.S. embassy in Bucharest.” –
According to Joe’s official statement from his 2014 visit in Romania, 2009 is also the year when he first made contact with the future chief of the local Anti-Corruption National Department (locally known as DNA), Laura Kovesi, back then just an ambitious prosecutor, now EU’s Prosecutor in Chief.
Laura, thank you for the introduction, but more importantly, thank you for your continuing involvement. As I — the first time our paths crossed was five years ago, as you said, and look at you now, pursuing an advanced degree, an advocate for international education. And you are a reflection of the progress your country has made and continues to make.
While leading DNA, with full support from US administration, Kovesi finished a process that started earlier: she decimated not only the local mafia, but basically any local capital that was strong enough to oppose foreign influence. One of Kovesi’s strongest opponents was a shadowy coalition of local tycoons known as The Monaco Group, after their preferred meeting place. The group was, and still is, headed by business mogul Puiu Popoviciu. This guy is the son-in-law of one of the darkest figures in Romania’s communist history, Ion “Teleaga” Dinca, former Minister of Internal Affairs and Vice-Prime-Minister under Ceausescu. Thus, he was deeply in involved with the former oligarchy and the secret services structures tied to it.
Coincidence or not, 2009 is also the year Popoviciu was hit with the only successful attempt by Romanian government to arrest him, a corruption file that will send ripple effects across the whole world.
After the 1989’s anti-communist “revolution”, in fact just a standard “orange revolution” (read “coup”), Romania has been ran and developed mainly with the capital and the data accumulated by the secret services operatives, who went on forming the Deep State of the new free Romania. Whatever external force wanted to do business in Romania had to negotiate with them. That’s not the case anymore, they’ve been slowly decimated by the Washington – Tel Aviv axis, which fully controls the state now, even the local mafia who only maintains local influence in the territory, but without access to the central commands, they can’t do much. Former prime-minister and socialist party leader Victor Ponta recalls in an interview that Kovesi had a direct phone link to Gitenstein, summoning the US administration’s help whenever she needed, as if the US Embassy was Aladin’s Lamp. And she used it to book the former socialist prime-minister Dragnea. Ponta said on video that Kovesi almost cancelled his official trip to US because he was supporting Dragnea. He eventually got to Washington, met Biden who told him “An independent Justice in Romania is very important for American companies”. Funnily, Popoviciu represents in Romania a host of top US companies, as shown further below. And Dragnea is now “prisoner to a circle of interests that roots in Israel, London and Washington”, according to his fromer colleague Ponta.
Vice President Biden visited Romania in 2014 and delivered a forceful speech against graft. “Corruption is a cancer, a cancer that eats away at a citizen’s faith in democracy,” he said. “Corruption is just another form of tyranny.”
2016: hunter enters the picture at the wrong time in the wrong place
2016 found Popoviciu desperately trying to escape a 9-year jail sentence for corruption, after the 2009 prosecution file we mentioned earlier came to fruition, the tycoon being convicted for scheming a public university and obtaining a bunch of valuable land for peanuts. Popoviciu launched an appeal. He assembled a high profile legal team to fight the conviction, which included former FBI director Louis Freeh, according to a release from Freeh’s firm. “We viewed Freeh as a guy who was wholly incompetent but who held on to power by making himself useful to the press and Republicans on the Hill,” says one Clinton White House aide. “He was a political opportunist who played Clinton, and he’s managed to escape the judgment of history for his mismanagement of the FBI.”
“In the final year of the Obama administration, an American lawyer traveled to Romania to meet with a businessman accused of orchestrating a corrupt land deal. The businessman was Gabriel “Puiu” Popoviciu, a wealthy Romanian real estate tycoon. The lawyer brought in to advise him was Hunter Biden, the son of then-Vice President Joe Biden, according to two people familiar with the matter. Hunter Biden’s work for Popoviciu in 2016 went unreported at the time, but Joe Biden’s involvement in Romania was very much public. The vice president was among the leading voices pushing the government to crack down on corruption.” NBC, Oct 2019
At the time he was brought in, Hunter Biden was performing work for the law firm Boies Schiller Flexner LLP where he was “of counsel.” He was no registered lobbyst, he had no reputation as a lawyer, but a massive one as crackhead. He had no skills or talents that could benefit Popoviciu, besides his family name. This was later confirmed by his former business partner Michael Bobulinski, who joined him in his Romanian trips and revealed that Hunter had zero expertise to recommend him for being in Romania.
Mr Popoviciu’s hiring of well-connected Americans seemed to be an effort to leverage “the importance to the Romanian government of the US-Romanian bilateral” relationship “to influence and possibly overcome his political challenges in Romania,” said Heather Conley, who was a deputy assistant secretary of state in the bureau of European and Eurasian affairs from 2001 to 2005.
Ms Conley, who is director of the Europe program at the Centre for Strategic and International Studies, warned that going to work in “environments where corruption is very prevalent, such as Romania, should be a blinking yellow light of caution reputationally for US firms and individuals.”
There’s a lot more to come out . . . Wait until we get to Romania
Rudy Giuliani in an appearance on Fox News
Here are a bunch of verified and accurate details NY Times revealed precisely one year ago, which both Biden and Trump are trying to sweep under the rugs: <<In 2015, before his first trip to Romania, Hunter Biden met with the Romanian ambassador to the United States in the country’s embassy in Washington, according to two people familiar with the meeting. Mr. Biden stressed that he was undertaking the trip as a private citizen, and did not expressly mention Mr. Popoviciu, or his case, one of the people said.
At one point, Hunter Biden approached Mark Gitenstein, a former American ambassador to Romania during President Barack Obama’s first term, to discuss the possibility of referring the Popoviciu case to Mr. Freeh, according to someone familiar with the conversation.
Mr. Gitenstein, who had served as a Senate aide for the senior Mr. Biden and now sits on the board of the Biden Foundation, defended the work of the prosecutors who targeted Mr. Popoviciu.
“Both the vice president and I had total confidence in the anti-corruption prosecutors in Romania, and did everything in our power to support them, both during our time in office and after,” Mr. Gitenstein said.
Mr. Mesires acknowledged that Hunter Biden referred Mr. Popoviciu to both Boies Schiller Flexner, the law firm where Hunter Biden worked at the time, and Mr. Freeh’s firm, Freeh Group International Solutions.
Mr. Popoviciu hired both firms, according to four people familiar with the arrangements. Mr. Popoviciu could not be reached for comment.
Boies Schiller Flexner declined to comment.
Mr. Freeh’s firm started work for the Romanian businessman in July 2016, shortly after Mr. Popoviciu was initially convicted by a Romanian court.
Mr. Freeh conducted a review of the case with a team of retired prosecutors and F.B.I. agents. The team concluded there were “numerous factual and legal deficiencies in the case,” according to a statement summarizing the findings issued in 2017, after the Romanian high court upheld Mr. Popoviciu’s conviction and handed down a seven-year prison sentence. Mr. Freeh called for Romanian authorities to review the case, and reach “another result.”
That has not happened. Mr. Popoviciu was arrested in London shortly after the high court’s decision. He posted bail and is fighting extradition to Romania.
While Mr. Biden ended his work on the case at some point after recruiting Mr. Freeh, Mr. Freeh continued working for Mr. Popoviciu.
Last year, Mr. Freeh retained Mr. Giuliani, a longtime associate whose 2008 presidential campaign Mr. Freeh supported, to help with his efforts in Romania.
In August 2018, while serving as Mr. Trump’s personal lawyer during the special counsel’s investigation into Russia’s election interference, Mr. Giuliani wrote a letter to Romania’s president criticizing the country’s anti-corruption prosecutors and urging amnesty to those who had been convicted in the crackdown.
That could have included Mr. Popoviciu, though Mr. Giuliani did not explicitly mention him in the letter. Mr. Giuliani said the Freeh Group was paying his fee, but did not identify the Freeh Group client on whose behalf he wrote the letter. However, he told Politico at the time that it “was based on a report I reviewed” by Mr. Freeh.
In the letter, Mr. Giuliani expressed concern about the “continuing damage to the rule of law being done under the guise of effective law enforcement” in Romania.
Less than two months earlier, the American embassy in Bucharest, along with the embassies of 11 other countries, had issued a statement reaching the opposite conclusion. It highlighted Romania’s “considerable progress” in combating corruption and in building an effective rule of law.
The statement, which came at a time when contentious alterations to the criminal code were moving through the Romanian parliament, also called on all parties involved to “avoid changes that would weaken the rule of law or Romania’s ability to fight crime or corruption.” >>
US Secretary of State assistant praises Romania’s fight against corruption
Successor to Joe Biden, The US Secretary of State’s assistant for Europe and Eurasia, Wess Mitchell, praised Romanian government’s fight against corruption same week Biden attacked it for threatening Kovesi’s position. Mitchell basically told Romania to keep it up.
“The progress Romania registered in combating corruption is impressive. We applaud it and urge you to continue, because this way you can eliminate the vulnerabilities that hostile powers can use to undermine the state from within,” Mitchell said in a speech at the Bucharest University’s Law Faculty. He added that the anticorruption institutions are proof that Romanians are brave in defending the liberties they fought for in 1989.
The US official also referred to Romania’s offshore legislation, which should be passed by the Parliament in the next period, saying that this should encourage investments in the Black Sea. He added that, by becoming a gas exporter, Romania can support Europe’s energy security on the long term.
US group ExxonMobil is involved together with local group OMV Petrom in the biggest offshore gas project in the Romanian Black Sea. They are also the most hated company by the Rockefellers.
a recap and some facts WESTERN MEDIA DIDN’T (WANT TO) PICK UP ON
So in 2009, Romania was aligned with many structures, from NATO to EU, complied with its allies and seemed like a well trained horse to jockey for the Tel Aviv – Washington axis. In fact, the local mafia was playing along but still held a lot of power, many connections in the East and Middle East, and a veto on anything. That was a liability for the new rulers. Obama assigned the area between Central Europe to Caucasus to Biden, who sent his pal Gitenstein to manage Romania, and together they started this offensive against local capitals and mafia, just to pave the way for their own. Together they groomed the future Chief Prosecutor Laura Kovesi, now a Trojan horse in the EU. And in the process they met a hard-to-crack nut: The Monaco Group /Puiu Popoviciu. A member of the group, Elan Schwartzenberg, admitted in a 2018 interview on the local B1 TV that Kovesi, in alliance with the new president Iohannis, was by far overpowering them. But they still had enough leverage to negotiate.
Popoviciu was not only backed by the former communist oligarchy, he IS also representing a host of US and International companies in Romania: Howard Johnson, Grand Plaza, Ramada Plaza și Ramada Parc, IKEA, Pizza Hut, KFC…
Popoviciu had the money to buy access to anyone and eventually his freedom. Which he did. He was released on bail, official sources told local tv station Stirileprotv.ro. The businessman has paid GBP 200,000, and has to wear an electronic bracelet. He is now wondering around London with a tracking bracelet on his leg, but less restrictions than the average Romanian under lockdown. Down from nine years of jail in Romania, the initial sentence proposed by Kovesi’s team.
Both Biden and Giuliani are boasting about their anti-corruption fight on TV while feeding on money from people like Popoviciu.
WHAT NO OTHER MEDIA WILL TELL YOU: shady deals with the us embassy for protection?
On 23rd of August 2006, one of Popoviciu’s companies, Baneasa Investment, rented 40,000 square meters of land to the US Embassy in Bucharest, then ran by Nicholas Taubman. The embassy sealed the deal for 99 years at the price of $8million. It may seem a lot, but the annual price per square meter was just around $2, while the market price in that area was around $150. The Romanian journalists who broke the story comment (video below, Romanian only for now): “At the time when this deal was closed, Popoviciu’s corruption case was clearly going against him already, and it’s more than likely this was his way to ensure some political protection from US. He has US citizenship and a long standing friendhsip with the embassy”. At the end of the video, a liberal senator asks on Romania’s prime news channel Antena3: “The suspicions against Popoviciu where so well known and so grounded it’s imaginable how the US Embassy could cut such a striking deal with him”. Here comes the best part: This plot the US Embassy in Bucharest sat on is part of the land involved in Popoviciu’s corruption file. A few ears after the 2006 deal, Beau Biden goes to inaugurate the new Embassy there. Then Hunter Biden goes to defend Popoviciu against Laura Kovesi for stealing that land, basically. All while Joe Biden was grooming Popoviciu’s prosecutor and playing the anti-corruption guardian of the Universe on TV. To add insult to injury, in 2018, Romanian courts orders that the land returns to state property. The Bucharest Court of Appeal has ruled that 224 hectares of land in Bucharest’s Baneasa area, where some of Bucharest’s biggest retail projects and the U.S. Embassy are located, must return to the state. The decision is not final and can be challenged, according to Digi24.ro.
Romania Insider reports, in December 2018: “The land targeted by this sentence currently belongs to Romanian investor Gabriel Popoviciu, who was convicted to seven years in jail, in August 2017, for having illegally obtained it from the Bucharest Agronomy University in the early 2000s. The High Court of Cassation and Justice ruled at that time that Popoviciu must return the land to the state.
According to the anticorruption prosecutors, the Agronomy University gave the land to Baneasa Investments, a company jointly owned by Gabriel Popoviciu and the University, at a value of USD 1 per sqm while the real value was some EUR 150 per sqm.
Baneasa Investments used the land to develop one of the biggest real estate projects in Bucharest, including office buildings that host the headquarters of several multinationals, the Baneasa mall and the first IKEA store in Romania. The U.S. Embassy also built its new headquarters on a land plot provided by Popoviciu.
Two firms registered in Cyprus and believed to be controlled by Popoviciu also filed a complaint against the Romanian state at the International Centre for Settlement of Investment Disputes (ICSID) in Washington. They accused Romania of breaching the bilateral treaty for protecting investments signed with Cyprus and asked for compensations of “at least USD 200 million”, according to media reports.”
Former prime-minister of Romania Victor Ponta recalls in his afore-mentioned interview: “In May 2014, Joe Biden came to Romania and gave a speech in which he said, among other things: ‘When politicians can be bought, when the courts can be manipulated, when the press becomes an instrument of propaganda, there you will find a society that can be manipulated from the outside, that loses control over its own destiny. Not only his political security, but also his physical security is compromised. We have seen in Ukraine how 15 years of corruption have undermined their system of military institutions and the country’s ability to defend itself. ‘
While Biden was saying all this, the American flag placed in honor of the high guest fell to the ground.” The story is confirmed by TV reports we have from that time.
Fast forward to June 2020: László Kövér, the leader of the Hungarian Parliament, accused Laura Kovesi, now chief prosecutor of the European Public Prosecutor’s Office, of being a foreign agent.
During the debate on the EU’s economic recovery package, László Kövér accused Laura Codruţa Kovesi of being a foreign agent and said that Ceausescu would be proud of her. Kover accuses Kovesi of gaining notoriety by launching dozens of investigations into political opponents, including Hungarian mayors.
Fidesz leader adds that hundreds of thousands of phone calls have been intercepted as a result of a collaboration between DNA and Secret Services
“They were completely unjustly accused, taken from their families at dawn in the car of a command unit. During this time, hundreds of thousands of phone calls were intercepted as a result of a collaboration between DNA and Security. Well, if Comrade Ceausescu were alive, he would be satisfied if he saw what she’s am doing in Romania “, said László Kövér, the leader of the Hungarian Parliament.
“How could Romania, as a state, remain functional as a result of such unforgivable activities, which clearly had external motivations, this is a matter that I leave to the judgment of the Romanian electorate. But is he really expected to join this European Prosecutor’s Office because he would be guided by a policy of impartiality, the rule of law and clean hands? ”, said Kover, according to 444.hu.
Commenting on Kover’s statement, Romanian analyst, former politician and definite Deep State operative, Cosmin Gusa says in a Facebook post: “Kover, publicly and OFFICIALLY revealing Laura Codruta Kovesi as “the agent of SOROS-type foreign powers”, gives us confirmation that at international diplomatic level Romania is perceived as a state led not by Romanians, but by others , a poor COLONY OF AN EXTERNAL CONJURATION difficult to identify precisely, and our leaders some useless puppets who do not exercise their constitutional role. We had the clearest recent evidence even by addressing the Coronavirus crisis, when our authorities directed their actions exactly in the spirit generated in the US by the phalanx “DEEP STATE – SOROS”, respectively in a spirit contrary to that desired by Donald Trump , the president of our so-called “strategic ally”. Which tells us clearly that our American partner was never the American state, but the “PREDATORY GROUP” in the DEEP STATE there, who through political puppets like Joe Biden and senior officers of their intelligence structures, took advantage and looted almost everything they grabbed from Ukraine, Romania and other weak states in Europe. The great shame felt by every Romanian who still possesses the feeling of NATIONAL PRIDE is one aspect, but what’s worse is to imagine how bad we will perform the near future, seeing that Romania is now perceived as being unmanaged, ready “TO BE DIVIDED BETWEEN THE GREAT AND INTERESTED PLANETS OF THE PLANET”…
Political partisanship makes Gusa separate Trump from international schemers, but it’s just a false impression, as Giuliani’s gig in Romania stands to prove, as well as Trump a.
October 2020: average Romanians enjoy less liberties than Puiu Popoviciu. Joe Biden advocates for masks, vaccines and quarantines. Kovesi is a great European prosecutor. Anti-corruption triumphs, people die of heart diseases at home, as hospitals are busy with propaganda. And when they get to the hospital, they die of Covid. #Justice.
To be updated
As promised, we follow up with important updates you don’t get many places, if any. Below we have e-mail evidence that The Bidens were developing more big businesses in Romania in 2017, at the same time as Joe was sweating hard fighting local corruption.
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! Articles can always be subject of later editing as a way of perfecting them
Can’t say I did it yet, but I’m willing to bet money that if we look into reports, around the world even, this is pretty common The amount of evidence you need to ignore these days to maintain a covidiotic look on the world is just insane. Our lives, rights and dreams are gone because of this.