Month: October 2007

NYT on fighting malaria with bednets

The New York Times ran a piece on distributing insecticide-treated nets for malaria today. It is an old story. There were long and tedious workshops on it at the last malaria conference I went to in Cameroon two years ago. I agree that bednets should be considered a social good, but it isn’t right to assume that every net distributed is a net used (and a life saved). It may be true that the very poorest don’t buy nets, but it is also true that many people (rich and poor) don’t use free nets, either. It isn’t just a technical problem of distribution, there are larger cultural, economic, and health issues.

When I went to Cameroon, I visited villages where ExxonMobil had said it had distributed thousands of free nets; and yet the people I met at the malaria clinic there said they didn’t know a single person who actually used one. I got the same response when I asked people at a malaria clinic in Malawi, and in Panama. They said the nets are hot, that people have different priorities (like using the netting for fishing, wedding veils, curtains), that the nets get holes in them, that malaria isn’t taken seriously enough, and so on.

It sounds nice for donors to be able to say they distributed lots and lots of free nets (marketing the nets is slower), but they should also track how many people actually use the nets.

Pfizer in Nigeria

Will the Nigerian charges against Pfizer change how drug companies conduct clinical trials in developing countries? I don’t think so. The Nigerian authorities seem to be more interested in sensationalizing the charges and catering to their own disgruntled populace. (And can we really expect the Nigerian government and an American company to come clean about what happened during that mengingitis epidemic in 1996? Evidence suggests that the Nigerian authorities were complicit in some way, just as they’ve been complicit for decades in Western oil companies’ exploitation of their citizenry in the Niger delta.)

What’s really needed is greater transparency, but the Nigerian authorities are not asking for that. They’re asking for payback. The bad PR that Pfizer will inevitably get may very well make drug companies more secretive about their activities in poor countries–which will make clinical trials more dangerous for trial subjects everywhere.

Interpol out to hunt down Pfizer execs?

Nigerian authorities have threatened to send Interpol to capture Pfizer staffers, after the nine Pfizer employees brought up on criminal charges in Nigeria failed to show up in court on Wednesday, after being served not just one but two summons.
“If they fail to appear in court” on November 6, the judge said, “we will have no option but to seek the help of Interpol in arresting them and bringing them to court.”
One suspects this is a ruse to appease a restive public–protests against Pfizer were in the works–while pumping up pressure to extract big dollars in a settlement. Out-of court talks to settle the case started in September, and are scheduled to resume on November 17…after the Pfizer folks stand trial.
The federal lawsuit against Pfizer was also adjourned, to October 22; and a final civil lawsuit was adjourned to December 5.
Stay tuned for more…

The patient recruitment bottleneck

For years, the drug industry has been plagued with the problem of finding enough human subjects to take experimental drugs. Each new drug they develop requires about 4,000 patients in clinical trials, who must undergo some 141 separate medical procedures. Increasingly, Americans and Western Europeans are just not that interested. Eighty percent of clinical trials in the West fail to recruit sufficient numbers of subjects, stalling the pace of drug development—and bleeding drug companies of some $1 million each day their potential blockbuster remains locked up in R&D.
Since the late 1990s, drug companies have routed this dilemma by exporting their clinical trials for new drugs to developing countries, where the sick and desperate abound. Last year, GlaxoSmithKline, Wyeth and Merck conducted at least half of their clinical trials for new drugs outside the major markets of the United States and Western Europe. In poorer countries, recruitment is rapid. In South Africa, for example, leading clinical trials company Quintiles reports it recruited 3,000 trial subjects in 9 days, and over 1,300 pediatric subjects in 12 days.
Easy, fast access to lots of sick, untreated patients is what drew Pfizer to Nigeria, too, where no informed consent forms were signed and where no witnesses could attest to the verbal consent the company alleges took place. Pfizer’s lack of documentation may be unusual but there’s plenty of evidence to suggest that the quality of consent in developing countries is generally poor, even when the forms are filled out. In studies in Bangladesh and South Africa, up to 80 percent of subjects enrolled in trials reported that they were unaware that they were free to leave the trial—a clear violation of the standard of voluntary informed consent.
In the West, up to 45 percent of subjects drop out of trials, providing post-factum confirmation of their voluntary consent. Dropouts are disturbingly scarce in trials in poor countries. One New-Delhi-based clinical trials company boasts, in its promotional literature, that it retains “99.5 percent” of enrolled subjects. “Russian subjects don’t miss appointments….and only very rarely do they withdraw their consent,” enthused a typical promotional Applied Clinical Trials article, “Discover Russia for Clinical Research.” “What a phenomenon!”
Pfizer didn’t have to alert the FDA and allow the agency to scrutinize its protocol before its scientists jetted off to Nigeria. Neither the FDA nor its counterpart in Europe requires prior review of trials that are conducted beyond US and EU borders, as they do with domestic trials. In the case of Pfizer in Nigeria, the ethics committee “approval” that the company provided to the FDA—and which the agency silently accepted, in its approval of the drug—was later shown by journalists to have been backdated, because there was no ethics committee at the local hospital when the trial took place.
But the most alarming part about drug company experiments overseas is how very little we know about them. Most drug companies aren’t sued by foreign governments for their unethical clinical trials. Most clinical trials overseas never see the light of day: after all, about 90 percent of drugs that enter clinical trials fail to gain market approval. No scientific papers or newspaper stories are written about them. Our regulators don’t know about them. These failed experiments effectively vanish as soon as they close down.
But while we blithely pop our prescription pills, a generalized sense of exploitation at the hands of Western drug companies grows, from South Africa where antiretroviral drugs are condemned to Nigeria where the polio vaccine was rejected. Unless we start to get serious about regulating these trials, Pfizer’s troubles in Nigeria will only inflame it, with public health impacts for us all.
Over the past few decades, pharma companies have circumvented complaints that they overprice their drugs and ignore the ills of the poor with subsidized drugs and private-public partnerships to spur drug development. But charitable works will not shield them from charges that their conduct of clinical trials on the poor is shoddy. Pfizer, rather than ducking the charges against it, should lead the call for increased regulation of overseas trials—for its own benefit, as well as the rest of us.

© 2024 Sonia Shah

Site by NormanUp ↑