Saturday, April 04, 2009

If There's A Hell, I Hope It's Spacious

Currently, the banksters are getting most of the bad press, but over the last four to six weeks, the pharmaceutical companies have had their share, and just as deservedly. The latest came in today's Washington Post.

Pfizer has reached a broad agreement to pay millions of dollars to Nigeria's Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic. ...

Nigerian authorities say Pfizer's infamous trial of the antibiotic Trovan killed 11 children and disabled scores more. The world's largest drug company says the deaths and injuries were the result of meningitis.

The response by Pfizer is a curious one. The children died of meningitis, the very infection their drug was supposed to cure. Something about that logic appears, at the very least, to be quite tortured. That might be because of the backstory:

Details of the drug trial were first made public more than eight years ago in a Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter. Researchers also gave children substandard doses of a comparison antibiotic, the articles added. ...

Trovan was never approved for use by American children. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned the drug in 1999.

Nice. Pfizer didn't take the standard and required steps for such a trial. It falsified a key document. It even messed with the dosage of the comparison drug, one that might have been less dangerous and more effective than Trovan. What the company did was go to a Third World country where it assumed it wouldn't get busted for such horrendous behavior. I mean, who cares about Nigerian kids?

And the time line is certainly interesting. The drug trial in Nigeria took place in 1996, and was clearly designed to be part of the research which would get the company FDA approval for the drug, which it got in 1998, but only for adults. However, the side effects even for adults were so bad that the FDA placed restrictions on its use and Europe banned it completely.

Twelve years later, Pfizer finally agreed to settle the criminal case by paying a fine, apparently of $75 million. In the general scheme of things, that's peanuts, and Pfizer knows it. The company is getting off cheaply, so cheaply that it no doubt made the whole escapade worth it.

Words fail me.



Blogger Fraud Guy said...

Welcome to risk management, where the only risk worth managing is cost.

10:05 PM  
Anonymous Anonymous said...

I liked this story better when it was called 'The Constant Gardener'

4:53 AM  
Anonymous Anonymous said...

I'd imagine that, for Pfizer, that's the price of doing business. The Post reported that sales of Trovan were over $160 million in the first year. That's sales, not profits, but I'd guess that makes the settlement much easier to tolerate -- if not quite "peanuts." I also suspect that they wouldn't have bothered with a drug that'd gross much less than that.

6:24 AM  
Blogger Libby Spencer said...


6:42 AM  
Anonymous Anonymous said...

"Something about that logic appears, at the very least, to be quite tortured."

Nothing about that logic is tortured.

Over 12,000 people died in the Kano meningitis epidemic. Pfizer is not accused of having caused any cases of meningitis. All of the 200 children treated by Pfizer came into the drug study already seriously ill with meningitis. There was no doubt when the study started that some of those children would die, whether or not they received treatment.

Of the 200 children in the study, 11 died - a much lower death rate than the death rate for meningitis patients overall in Kano. The main accusation against Pfizer is that it did not obtain proper consents from parents. That appears to be true. But these were parents of children who were likely to die if they did not receive treatment, because the death rate among infected children was approaching 90%.

You can argue persuasively that Pfizer behaved unethically, in that it did things that it never would have done in a Western country. But you cannot contend that Pfizer's actions did not save lives. Children who would have died are alive today because they were lucky enough to have participated in the study.

9:55 AM  
Blogger Jeany said...

I'll bet in Pfizer took that case to the Supreme Court, they could get that fine reduced by about 90%. It's really big-hearted of them to pay now instead of dragging it out for another decade or so.

10:53 AM  
Blogger shadowfax said...

Ditto what Anon 9:55 said. Trovan was a great antibiotic in that it worked really well against a broad spectrum of bugs. Certainly, it was a legitimate line of research to test it as an agent of last resort in meningitis -- there was very good reason to think that it would prove superior. I thought it got a bum rap and pulled from the market prematurely, but whatever.

Either way, the valid accusations against Pfizer seem to be ethical breaches, not manslaughter.

10:54 AM  
Anonymous Anonymous said...

Anon 9:55 is bang-on. If any of us had been on the ground during this meningitis epidemic, and we had been given the choice between using this drug, and getting proper approval, which one of us would have hesitated? I know I wouldn't have. This is not Tuskegee.

1:13 PM  
Anonymous mdh said...

Q" "If any of us had been on the ground during this meningitis epidemic, and we had been given the choice between using this drug, and getting proper approval, which one of us would have hesitated?

A: Any of 'us' with medical training.

First, do no harm.

1:23 PM  
Anonymous Anonymous said...

Ditto what the Anonymous Pfizer reps are saying.

2:23 PM  
Anonymous Anonymous said...

All right, we have three comments from people who appear to have some idea what they're talking about, and a comment by someone who contributes nothing except an an supported accusation that knowing what you're talking about demonstrates that you're a corporate rep. I'm a pretty far left liberal, but I've never joined the small fringe on the left that believes that only ignorance guarantees ideological purity.

I arrived here from Atrios. I won't be back.

7:50 PM  
Blogger Pharmawatch said...

I don't understand where all the bile against Pfizer was coming from. About 94.4 percent of those who participoated in the Trovan study survived as against the 90 percent achieved by Doctors Without Borders. Nobody ever accused DWB of murder because everyone realised that well over 12,000 children died of meningitis that year. It was a terrible epidemic. Pfizer has partnered Nigeria for about 50 years and had contributed greatly to the development of the healthcare sector. Many commentators out of ignorance accuse Pfizer of killing people. What arrant nonesense! I am a Nigerian pharmacologist and I live in northern Nigeria. My country is not a banana republic where a pharmaceutical company can just stroll in and conduct trials without government permission and the consent of regulatory agencies. It may be convenient for some people now to deny issuing permit for the trial. Their ugly backsides would have been ripped open if the litigation had run its full course. I think it was smart of the Kano State Government to agree to out-of-court settlement. The facts contained in Pfizer's defence filed at the courts totally debunk all the allegations. Now that settlement is imminent, as a Nigerian patriot I would advise both the Kano State Government and Pfizer to ensure that due diligence is carried out when disbursing funds. All those coming forward for compensation have to be authenticated through DNA. The funds allocated to the rehabilitation of the Infectious Diseases Hospital must be administered by a neutral third party made up of men and women of high integrity. This is to ensure that the money does not end up in private bank accounts of greedy functionaries and pseudo ombudsmen. Indeed Pfizer would be a fool to simply drop their check and walk away. The challenge now is how to ensure that Transparency rules the waves while greed is consigned to the back burner.

3:07 AM  
Blogger Jeff said...

Nice spin, oh brave Anonymous reps from the Phizer corporation. I'm glad they're spending money on blog comments to protect their reputation rather than coming up with new drugs that don't kill people.

But all this spin ignores that fact that no matter what you say about the drug or the study, it was done illegally, with falsified documents, in a third world country, and as part of the study which the court seems to think was rigged to make the comparison drug look weaker than it actually was.

If you think that's heroic work, Satan is proud to have you on the team. If this is such a good drug, with some minor side effects (like death and liver failure), why oh why would the EU ban it completely? Clearly the research doesn't back up your spin, but certainly, keep trying. It is important to make sure Phizer doesn't look bad from this, and after all, it would be rather pointless to have sold your soul to a monster by admitting it. But that money must spend good.

7:18 AM  
Anonymous Anonymous said...

I am curious about the "disabled scores more." Is this liver damage?

I am really curious about what people expect from corporations. Corporations exist to provide shareholder value. Corporations do not have morals. Corporations don't have any ethical requirements. That is why we have government regulations.

Do not expect a corporation to police itself.

12:06 PM  
Anonymous exarch said...

I assume the "disabilities" referred to in the article may be neurological damage including things like hearing loss, epilepsy, learning difficulties and even decreased intelligence, all of which are typical results occuring in meningitis survivors (about 15%) according to wikipedia.

It seems a lot of details surrounding this issue are shrouded in non-disclosure, but it seems to me like it's mostly a dispute about approvals and other similar paperwork, not about negligent homicide as some scare mongerers would have you believe.

Please do your research.

9:02 AM  
Anonymous exarch said...

I am not a Big Pharmaâ„¢ representative, or even in the medical business, but I'll wager a guess in response to Jeff's question:

The reason it was banned in the EU is most likely because from what I can gather, Trovan is a broad spectrum antibiotic. The side effects are worse or more prevalent, but the survival rate when you're not quite sure what you're dealing with, is higher none the less.

So when you're in a third world country with less than ideal medical infrastructure, it would be a better choice than conventional antibiotics.

On the other hand, when you're in Europe, the risks don't outweigh the benefit of a cure-all antibiotic. You probably don't even need one because a better or earlier diagnosis would mean you can get something much safer and more specific than whatever happens to be in stock (like a doctor without borders might have with them whenever a sudden epidemic outbreak of meningitis occurs).

9:18 AM  
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