U.S. diplomatic cables made public by WikiLeaks show that drugmaker Pfizer hired investigators to find evidence of corruption against Nigeria's attorney general, in an effort to convince him to drop legal action against the company.
Pfizer was sued for $2 billion over testing of the meningitis drug Trovan. Nigerian authorities said the tests killed 11 children and left dozens disabled. Pfizer eventually agreed to a $75 million settlement.
"... [A] memo leaked by WikiLeaks referenced a meeting between Pfizer's country manager, Enrico Liggeri, and U.S. officials suggesting the drug company did not want to pay to settle two cases brought by Nigeria's federal government ... Pfizer had hired investigators to uncover corruption links to federal Attorney General Michael Aondoakaa ... Pfizer's investigators were passing this information to local media."
A series of damaging articles detailing Aondoakaa's alleged corruption ties were published by local news agencies subsequent to the meeting.
One of the patterns that make me most angry with multi-national drug corporations is their commitment to the corporate mantra of maximizing profits for their shareholders at any cost, including that of human lives.
Releasing poorly tested drugs, or drugs with "safety data" based on manipulated or fabricated studies is bad enough. But despite The Nuremberg Code—developed in the aftermath of the medical atrocities that occurred during World War II—drug trials sorely lacking in ethics are still conducted all over the world, and usually involve the most defenseless of all: children.
The Nuremberg Code provides guidelines to protect human experimental subjects from injury, disability or death. One of its main principles is that you must obtain voluntary informed consent from the patient about to be experimented on.
However, the US government offers compelling incentives to pharmaceutical companies to test new drugs, or drugs previously only approved for adults, on children (many of which take place in developing countries).
By giving drug companies who conduct pediatric drug testing a "pediatric exclusivity provision," which gives them an additional six months of patent protection on the drug in question.
Six months may not sound like much, but the profits from this market exclusivity can easily be in the millions for any particular drug. As a result, some drugs that were already thought dangerous for adults have been subsequently tested on children—logic be damned.
In the case of Pfizer killing African children during an allegedly illegal drug trial, we're faced with not one, but two troublesome issues:
- Testing a dangerous drug on children, and
- Conducting this risky testing on underprivileged children in a developing country, without obtaining informed consent
Nigerian Families Sue Pfizer Over Death and Disability in Illegal Drug Trial
Those of you who saw the film "The Constant Gardener" will likely recognize the similarities between these stories. The film highlights the exploitation of destitute, illiterate Africans enrolled in drug trials without informed consent—with deadly consequences.
In the same vein, "a panel of Nigerian medical experts has concluded that Pfizer Inc. violated international law during a 1996 epidemic by testing an unapproved drug on children with brain infections at a field hospital," the Washington Post reported in May 2006.
According to Nigerian authorities, Pfizer's illegal actions killed 11 children and left dozens disabled.
The drug in question was Trovan, a meningitis drug that was eventually approved in 1998 for adult use only. However, after reports of liver failure began emerging the US restricted the drug to adult emergency care only, while the European Union banned it in 1999 due to its health risks.
A 2006 article in the Washington Post described the case against Pfizer:
"… 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."
The test came to public attention in December 2000, when The Post published the results of a year-long investigation into overseas pharmaceutical testing. The news was met in Nigeria with street demonstrations, lawsuits and demands for reform.
The panel [of Nigerian medical experts] said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records documenting that Pfizer told the children or their parents that they were part of an experiment, it said.
An approval letter from a Nigerian ethics committee, which Pfizer used to justify its actions had been concocted and backdated by the company's lead researcher in Kano, the report said.
The panel concluded that the experiment violated Nigerian law, the international Declaration of Helsinki that governs ethical medical research and the U.N. Convention on the Rights of the Child."
Thirty Nigerian families whose children were part of the Trovan trial filed suit against Pfizer in August 2001 under the Alien Tort Claims Act, in order to have the case heard in the US instead of in Nigeria. That case is still pending under a federal judge in New York.
However, the scandal also led to Pfizer being sued for $2 billion by the Nigerian government in May 2007, and it is this lawsuit that the Wikileaks cable refers to.
On July 30, 2010, Pfizer agreed to pay a $75 million settlement to have the Kano state civil and criminal charges dropped. But according to leaked US diplomatic cables, Pfizer allegedly conspired to extort Nigeria's attorney general to drop the charges instead of having to pay up.
"… [A] memo leaked by WikiLeaks referenced a meeting between Pfizer's country manager, Enrico Liggeri, and U.S. officials, suggesting the drug company did not want to pay to settle two cases brought by Nigeria's federal government…
"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," according to an April 2009 cable from Economic Counselor Robert Tansey of the U.S. Embassy in Abuja…"
Unethical Drug Trials Overseas: A Growing Problem
According to a recent investigative report published by Vanity Fair, 6,485 clinical drug trials were conducted overseas in 2008—drugs designated for the US market. In comparison, there were only 271 overseas trials in 1990. And tracking of these trials is virtually non-existent.
"A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000," Vanity Fair states.
"In 2008 alone, according to the inspector general's report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials."
However, these numbers may be significantly lower than the reality, because companies are not required to report studies conducted overseas, and many don't.
There's also very little accountability in terms of the accuracy of these trials as well.
"It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals ... Today it is mainly independent contractors who recruit potential patients both in the U.S. and -- increasingly – overseas," Vanity Fair states.
"They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals, and create promotional campaigns."
I highly recommend you read the Vanity Fair report in its entirety. It's an eye-opener...
These unethical drug trials exact a heavy toll on human life and violate our most basic freedoms.
For example, at least a dozen infants died while part of a clinical study to test a pneumonia vaccine in Argentina two years ago. The study was sponsored by GlaxoSmithKline, and used children from poor families. According to the Argentine Federation of Health Professionals, the families were "pressured and forced into signing consent forms."
More recently, the Indian government recently suspended Merck's Gardasil study after they discovered that four of the young participants had died, and more than 120 girls suffered severe adverse reactions.
The suspension came about because of a civil society-led investigation which highlighted serious ethical violations in at least one trial. According to Economic & Political Weekly:
"... [T]hese projects – which were in fact research – violated existing ethical guidelines on clinical research, as well as child rights.
These violations include – but are not limited to – testing on vulnerable and marginalized groups (particularly pediatric populations), who are not likely to benefit from the results of the research, and without taking their proper informed consent or assent."
Again and again we see how major drug companies scheme to enlist unsuspecting human guinea pigs in their experiments. In fact, this seems to be more the rule than the exception.
India in particular has seen an upsurge of clinical pharmaceutical studies, and the questionable practices employed are becoming increasingly apparent. So much so that India is now proposing new laws to prevent pharmaceutical companies from conducting clinical drug trials involving humans without first obtaining permission from an accredited ethics committee, according to an article published last June.
The article goes on to say that:
"Deaths during clinical trials are increasing in India in the recent years even as the country emerges to be one of the most sought-after destinations of human studies of experimental medicines.
According to the figures collated with available information collected, as many as 308 persons died in the year 2009 till the month of August..."
"Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010"
That's the title of a newly released report by the Public Citizen's Health Research Group.
According to this report:
"Of the 165 settlements comprising $19.8 billion in penalties during this 20-year interval, 73 percent of the settlements (121) and 75 percent of the penalties ($14.8 billion) have occurred in just the past five years (2006-2010).
Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades.
These leading violators were among the world's largest pharmaceutical companies."
All in all, however, no less than 19 drug companies made AllBusiness.com's Top 100 Corporate Criminals List for the 1990s.
Quite literally, our conventional "health" system is driven and manipulated by some of the top corporate criminals in the world! Is it any wonder that they have no qualms about allegedly sacrificing the poor and the illiterate to increase their own profits?
I think not. In fact, you'd have to be incredibly naive to think otherwise.
Perhaps increased litigation against them will slow them down. Pfizer officials are even being sued by their own investors now, for knowingly marketing their drugs illegally while betting the consequences would be negligible, and for systematically disregarding the laws governing their business.
Then again, we also saw how Pfizer was recently deemed "too big to nail," despite overwhelming evidence of criminal misdoing...
And even when settlements are agreed upon, the fines they pay typically amount to a month's worth or so of profit. It's literally a drop in the bucket when you look at how much money many of these dangerous drugs rake in.
I don't think this is the last time we'll learn more than we've ever wanted to know about the seedy underbelly of the pharmaceutical industry.
The real take-home message from all this is that your health belongs totally to you. No one else is responsible for it, and no one else—least of all a drug maker—will take responsibility for treatment gone bad.
Always remember that drugs are rarely anything more than a short-term band-aid to your health problems.
Some drugs are convenient short-term fixes for acute problems (like a headache), for which most of us are grateful, but problems arise when you believe the deception that these multi-national drug corporations have created, and choose drugs as the long-term answer to your health challenges.
Life would be grand if we could just swallow a pill and all our health problems would be solved. But believing this fairy tale will only make these companies wealthier, while putting you at risk for serious side effects or even death, like the 60,000 men and women who chose Vioxx as their band-aid solution.
My best advice: Strive to better understand and treat the real problem behind your medical condition. There are hundreds of thousands of pages of free information on this site designed to help you achieve that goal. Remember to use the site search engine to find more information on your health questions.