Several weeks ago the Nigerian government announced a $7 billion action against Pfizer for
performing tests on children during a 1996 epidemic without informed consent. This story was one of four cases highlighted in an excellent documentary made by Michael Simkin and Brian Woods for Channel 4 in 2003, called “Dying For Drugs.”
Kano, a town in northern Nigeria, was already in the grip of cholera and measles epidemics when another disease struck: meningitis. Infection spread rapidly and hundreds died. MSF set up an emergency operation there to treat the sick with proven antibiotics. A couple of weeks later Pfizer independently dispatched a team to Nigeria with their new drug Trovan, which had never been tested on children. Pfizer has never produced any consent forms signed by either the children or the parents, claiming that the risks were explained by a local nurse and consent was ‘verbal‘. Over two hundred children were experimented on as part of this trial.
Pharmaceutical tests are required to be cleared in advance by an Ethics Committee. In this case it was notionally based in Aminu Kano Teaching Hospital, but in fact does not appear to have existed. Pfizer produced a letter dated March 26, 1996, but later their doctor admitted that he had produced the letter a year later and backdated it to reflect what he claims was a ‘verbal agreement’.
Pfizer later fired one of its child health specialists, Juan Walterspiel, after he wrote an open letter to senior management outlining criticism and concern at the way in which the trials had been conducted. He is not the only Pfizer employee to have been fired for whistle-blowing.
Apart from the Nigerian government’s action, there is a separate case underway in the High Cort in Kano, taken by the state and the families of the children involved. At least five children die, and many others have suffered from arthritis; Trovan was known to have the side effect of causing joint damage. Lawyers representing the families initially sought to have the case heard in the US under the Alien Tort Claims Act, a move which Pfizer’s lawyers fought.
The Food and Drugs Administration eventually granted approval for use on adults in the US, but not on children. Following the exposure of liver related conditions its use was further circumscribed. Trovan has not been approved for use in Europe.
Further information is available in an article published by the Washington Post in 2000, as part of its series “The Body Hunters”, “As Drug testing Spreads, Profits and Lives Hang in the Balance.”
Other chapters in Dying for Drugs chronicle Big Pharma’s modus operandi in three other areas: silencing critical medical research; pharmaceutical pricing; effects of compulsory licenses (and their absence) on the lives of AIDS patients. Director Brian Woods met John Le Carre and Fernando Mereilles during production of “The Constant Gardener” in 2005, and copies of the film were distributed to members of the cast.
As mentioned elsewhere, I haven’t missed the Fordham IIP conference for years. Oriented largely towards the intellectual property industry, both in the sense of practitioners and those industries driving up the protection rachet, the value I extract from it is in inverse relation to the sympathy that I feel with the perspectives usually expressed; I learn from listening to those whose views I oppose. Unfortunately this year my participation was curtailed due to work commitments, so I missed an essential part of the gig, namely compere High Hansen’s acidic jokes at the expense of all the nabobs present. My pal Mako suggests that this is in fact the secret elixir behind the events repeated success: the bigwigs come with sado-masochistic urges, to see/hear themselves abused by Hansen, and take pleasure in the sight of others receiving the same treatment. Perhapa this is a case for Slavoj Zizek?
At this point in the IP wars everyone has their roles well-rehearsed, so there were relatively few surprises or revelations. PhRMA representatives, media industry types etc bemoaned the fact that the oodles of extra protection they’ve received in recent years are insufficient to protect the vital work they’re carrying out from the assault by nasty pirates. Yawn. We heard from the IFPI how the three step test in the Berne/WTO convention on limitations and exceptions to copyright protection is excessively promiscuous, but they would say that, wouldn’t they.
Later there was a debate about the use of compulsory licenses on pharmaceutical products in Thailand, a current hotspot for this conflict (along with Brazil and India). The Thai government has issued CLs on second generation AIDS treatments along with another drug for treating heart disease, enabling them to make treatment accessible for their citizens at much reduced prces. Opponents to this policy have learned a thing or two over the years, so there was no vulgar ‘let them pay or let them die‘ talk. Instead the adversaries were incredibly boring and emphasised supposed procedural faux-pas committed by the new (military) government rather than arguing the policy.
Jamie Love made his usual well informed contributuon, pointing out that Italy has issued compulsory licenses on several occasions in recent years without great controversey (most recently a prostrate drug in March of this year). One deduces that it is a lot more difficult to demonize, isolate and berate an EU country following a progressive policy on these subjects than is the case with a nation in south-east Asia. Industry representatives pointed out that Thai government ministers are raising their own salaries of its own ministers whilst cutting the health budget, and this is a valid point: politicians suck and line their own pockets (universal truth) but that’s no reason to pay the extortionate prices charged by the pharamaceutical industry as a global racketeering operation.
During the next session there was an update from Victoria Espinel of the United States Trade Representative, which is not an institution I like. Their most recent sin is their annual section 301 report ( a sort of grade-card on each country’s compliance with US interpretations of international copyright standards). She was all excited because they have just been allocated a whole new office dedicated entirely to IP and Innovation. This is worrying as a text-book example of institutional behaviour: the USTR has grown on the back of an aggressive expansionist IP policy, which is now being consolidated in the institutional DNA – a seperate new office can only be understood as a reward for their contribution so far, so the message is obviously continue on the same tack…
Espinel did have one positive nugget to communicate however, which is that with the recent Democrat takeover of the House Way and Means Committee there is apparently pressue on to revisit some of the terms of recent Bilateral Trade Agreements with developing countries. Panama, Peru and Colombia have all recently signed deals with the US and it seems that many democrats regard the IP tems as having been too exacting and wish to relax some elements, which is good news.
Via e-laser, a pointer to a recent article, Scrooge and intellectual property rights, by Joseph Stiglitz, former chief economist at the World Bank, and renegade for whistling in church during the the neo-liberal liturgy. His piece in the British Medical Journal is a call for the creation of prize funds to incentify public medical research. This is an idea being pushed by Jamie Love from the Consumer Project on Technology and Access to Essential medicines campaign, whose submission to the WHO is cited by Stiglitz.
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