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Inhaled insulin and drug marketing practices

Inhaled insulin: Here’s a great illustration of how disconnected the drug industry has become from public health….or even individual peoples’ health. When I went to a industry conference a few years back, Pfizer execs were gloating over their great new experimental product, a form of inhaled insulin. The drug was still in clinical trials–meaning they couldn’t have known whether it was truly safe and effective or whether it was any better than injected insulin–but they were certain that it would be a blockbuster. Because, of course, whether the drug was effective or any better than what we already have was irrelevant. Inhaled insulin is a great idea, in principle, and the obvious plan was to harangue patients with marketing so they’d switch to it on that basis alone.

Well, Pfizer’s drug, Exubera, was a bust. They “only” sold $12 million worth of it, and so now they are going to stop selling it! First it was the best thing since sliced bread, but now…since they aren’t making the billions they foresaw, they’re dumping it. So much for those users who did switch and actually liked it. They’re screwed.

Basically, the drug was a bust because it was no better than injected insulin and on top of that, it messed up patients’ lungs. A total disaster.

Now, a new company called Mannkind, backed by a billionaire investor, is launching a new inhaled insulin called Technosphere Insulin, similarly gloating–while the drug is still in clinical trials–that they will make billions on the thing. The New York Times business section featured their glossy PR in an article this morning, replete with a large pic of the billionaire investor looking smug in his grand digs. He might as well have had dollar signs tattooed on his eyeballs.

Buried near the end of the story we learn that–already!–more patients taking the inhaled insulin have dropped out of clinical trials than patients taking the old standby, injected insulin! “For reasons that are not yet clear”! Well, there can’t be any reason, in my mind, that doesn’t bode poorly for the inhaled insulin. They didn’t like it, they had adverse effects, or whatever.

And, the chief medical officer has accused the company of hiding information about the drug from the FDA! The company, in response, fired him. But we’ll never learn about the dirt he found because his wrongful termination suit has been settled out of court!

This thing seriously stinks. And it is all the more remarkable for the fact that all of this dirty laundry about the drug is tucked into what is overall a glowing business story.

Check it out: http://www.nytimes.com/2007/11/16/business/16mannkind.html?_r=1&oref=slogin

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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.

Posted in: Books, The Fever
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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.

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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…

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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.

Posted in: The Body Hunters
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Newsweek gets it wrong on malaria

Newsweek’s short piece on malaria in Africa (September 24, 2007) is full of misinformation and mythology. For example, there has never been any continent-wide malaria control in Africa, as the lead sentence brazenly states; mosquitoes develop resistance to DDT by exposure to brand-name pesticides sold by Western chemical companies like BASF and others, not just by African farmers illegally using DDT on their fields; the main reason DDT wasn’t used in Africa for so long is because the EU and others told African farmers they wouldn’t buy their farm products if they did; and there’s evidence to suggest that malaria problem in Zambia has not gotten better, it has been worsening, and the mining companies’ whose work the article lauds have been the subject of riots.
None of these counter-points are speculative but near-consensus opinions in the malaria field. It is strange to see the mainstream press diverge so much from expert opinion: smells to me like politics eclipsing science.
Check it out: The Doomsday Spray: To fight malaria, African nations are turning to DDT.

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Nigeria charges Pfizer for unethical Trovan trial

Nigerian authorities slapped criminal charges on Pfizer this month, alleging that the company’s infamous 1996 botched antibiotic trial there was “rash and negligent,” and endangered lives.
Some of the subjects in the trial died, others suffered permanent disability, and the prosecutors say it’s Pfizer’s fault for providing a too-low dose of its comparator drug. (Listen to stories on NPR and ABC Australia, which feature a few quotes from me, for details.)
That’s a medical question on which the experts are not unanimous. Kids die from meningitis and are permanently disabled by it, too.
Less debatable is the fact that Pfizer violated international ethics standards and their subjects’ human rights. In a separate class-action suit against the company, the subjects said that they didn’t know they were in an experiment, and the company did not produce signed informed consent forms. The ethics committee “approval” the company produced later turned out to have been backdated.
This is the first time a state has filed criminal charges against a drug company, but I doubt it will be the last. With 80 percent of clinical trials failing to meet recruitment deadlines in the West, major drug companies are today conducting half or more of their trials outside the major markets, often in countries–like Nigeria–with poor human rights records and weak regulatory infrastructures. Pfizer’s Nigeria trial is unusually sensational and high profile, but its bending of the rules may be more the rule than the exception.

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The Internationalist (an interview)

A short but pointed interview with me appears in The Internationalist this week, along with a cool watercolor portrait (!). Check it out at The Internationalist.

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Will genetically modified mosquitoes end malaria?

I recently asked a bunch ofnurses at a NIH-funded malaria research clinic in Malawi where all thelocal malarial mosquitoes bred, and they answered in unison–“in theswamp.” Not so, said the mosquito biologist in the next building over.In fact the bugs that were killing their patients nursed their young inthe puddles right outside the hospital’s unscreened windows.
To think that we could develop a man-made mosquito–our ownsuper-mozzie–more adept than those in the wild, with their greatdiversity of habits and lifestyles greatly underestimates the wilinessof these dappled flies. Stalked by pathogens, relied upon by no creature,these insects have thrived for over 100 million years, in almost everyplace where the sun shines and the rain falls, however seldom. They’refantastically good at it. Some GM mosquito might beat a few of thesehardy survivors, in some places, at some times, but they couldn’t beatthem everywhere.
GM mosquitoes surely will teach us somethingabout the spread of malaria but they won’t end it. As with DDT, there’sno one-size-fits-all solution to malaria, our most ancient scourge, tryas we might to find one.

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NEJM on The Body Hunters

From this week’s New England Journal of Medicine: a review of The Body Hunters by Johns Hopkins University’s Jeremy Sugarman, MD, MPH:

“An accessible account… important…powerful…derive[d] from a rich set of sources…. It is critical that those engaged in drug development, clinical research and its oversight, research ethics, and policy know about these stories.” —NEJM, December 7, 2006

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