Pfizer's "Blockbuster" Drug Turns Out to be a Nightmare
Could it be that Big Pharma giant Pfizer used Nigerian children as guinea pigs in a trial they knew would never fly in the United States?
In yesterday’s article (“Pfizer to answer for testing unapproved drug on Nigerian children”), I told you about Pfizer’s decision to settle a lawsuit accusing them of testing a dangerous drug on children without full disclosure to their families.
Then Pfizer researchers traveled to the Kano state of Nigeria during a 1996 meningitis epidemic, they must have had visions of dollar signs dancing before their eyes.
Initial tests had raised hopes that Trovan, up until that point only used intravenously, could be effective if swallowed in tablet form. If all went well in trials, Pfizer could have a “blockbuster” drug on its hands.
Trovan, also known as Trovafloxacin, was approved by the US Food and Drug Administration (FDA) in 1997 to treat a broad range of infections, but its use was severely restricted in 1999 after being linked to a high risk of liver failure, which in some cases occurred only two days after treatment. The drug was flat-out banned in Europe around the same time.
The drug trial in Nigeria took place in the spring of 1996—so you could make the case that the dangerous side effects of Trovan weren’t known at the time. In fact, that’s the line that’s been faithfully recited by Pfizer reps. But it doesn’t add up...
The side effects of the drug group that Trovan belongs to were documented no later than 1992. Side effects of these drugs are severe—they have been linked to joint disease and abnormal cartilage growth in addition to severe liver damage.
Pfizer wanted to prove Trovan not only worked orally, but also that it worked on children. But they had a problem. To get approval from the FDA, they needed to conduct a clinical trial. Parents in the U.S. and Europe are (rightfully) leery of offering up their children for drug trials. So companies often turn to poor countries, where parents are less informed and more desperate—they just want something to work.
Of course, there are still rules. Pfizer was supposed to explain that the drug was in the test phase, and that its safety had not yet been proven. Parents are also supposed to be made aware that alternative, proven, medicines is available. And that they have the right to exit the study at any time.
But it looks as if none of that was communicated. Parents who were interviewed after the trial said they’d just heard that doctors were offering help, and were never told this was a drug trial.
It gets worse. One parent claims that her child who was brought in for treatment started showing signs of paralysis and complained of severe pain. Another child, identified only as Patient No. 0069, was given Trovan for three days as her condition worsened. She died without receiving any other antibiotic, even though international guidelines for clinical studies explicitly state that patients who do not react to test drugs should be immediately removed from the study.
Though Pfizer maintains its pride in the way the trial was conducted, claiming they’ve always had Nigeria’s best health interests at heart, they are willing to settle the lawsuit.
So now they can brush it under the rug once and for all. Though they’ve been doing a pretty good job of that all along.
If you haven’t heard of this despite the fact it’s been going on for over ten years, it’s really no surprise. Stories of the trial have been tucked away in Business sections of online news sites, including the BBC.
A Google search of the terms Pfizer and Nigeria turns up some interesting results. At the top of the page are three links concerning this news story, but then the results are broken up by a selection of paid links to pages on Pfizer’s own website—pages that have absolutely nothing to do with the trial in Nigeria or the resulting legal battle.
Sources:
"Pfizer near $75 mln settlement with Nigeria." Reuters (www.reuters.com), 4/1/09.
"Deal in Pfizer-Nigeria drugs suit." BBC News (news.bbc.co.uk), 4/9/09.
"Nigeria Takes on Pfizer over controversial drug test." Spiegel (www.spiegel.de), 11/16/07.
"Panel Faults Pfizer in '96 Clinical Trial In Nigeria." Washington Post (www.washingtonpost.com), 5/7/06.
"Trovan tablets/Trovan I.V." Pfizer (www.pfizer.com).
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Christine O'Brien writes the e-letter Health eTips for Dr. Wright's Nutrition and Healing.
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Comments
Ruthjones
Christine, this is an interesting perspective. You make it sound as if drug trials are mortal sins. If drugs are not tried how will medical science advance? I quite agree that rules have to be followed but there are lots of challenges in that regard in developing countries. That problem can only be removed if we legislate drug trials in third world countries out of existence. Those who talk about pharmaceutical companies sneaking into African countries don’t know what they are talking about. Try getting a visa to Nigeria and you will know that it is like a camel squeezing through the eye of a needle. You simply can’t enter Nigeria if the authorities don’t want you to. What about the importation of the medical equipment and loads of drugs? They have to be cleared speedily at the ports with government facilitation. So, if anything went wrong in the Trovan trials of 1996 the Nigerian and Kano governments can’t wash their hands off like Pontius Pilate. An informative article on the challenges of off-shore clinical trials can be read on http://www.nationalpost.com/ne...
To show how complicated the whole issue could be, you ironically referenced Der Spiegel. But it was that same journal that carried a photograph of one Anas Mohammed as one of the patients destroyed by Trovan. The story said Anas Mohammed had lost his senses of hearing and speech and had in short been reduced to a virtual vegetable. But it turned out that Anas was never in the Trovan group but in the control group and that he was hale and hearty. I understand that Der Spiegel had since apologized over their mistake. A review of some of the issues involved in the case is available at http://pharmamonitor.blogspot....
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