2249 Something New

Monday, February 2, 2009

I suppose if I had thought about the subject at all, I'd wouldn't be surprised by this. We all know that drug companies run clinical trials. Jay was in several for his brain cancer. I didn't realize that American pharmaceutical companies ran clinical trials in other countries - especially what are considered "third world" countries. Of course, if I'd thought about it....

In the U.S., patients and families get a lot of detailed information on the medication or treatment on trial, including possible side effects, no matter how rare. If a new, unexpected, side effect shows up, the entire trial is halted because it can run only under the original terms that the patients had agreed to. And if it becomes apparent that the new treatment is not as least as effective as the current standard treatment for this phase of the illness, the trial is halted (which is why for many trials, a patient is not accepted if the standard treatment is working).

I can't help wondering if the above requirements are upheld in the other countries that the pharmaceutical companies select for clinical trials.

This synopsis from the Wall Street Journal outlines a complaint filed by 88 Nigerian families against Pfizer, that the company had tested a new drug on their children without their knowledge or permission.

...
In the ruling, the majority and dissent, notes the NYLJ, differed over whether the families’ claims that their children had been subjected to medical experimentation without their consent fell within the Alien Tort Statute, the 1789 law that gives foreigners the right to raise tort claims in federal court to vindicate violations of “the laws of nations.”

In a statement, Pfizer said its 1996 clinical study was conducted with the consent of the children’s parents and “was consistent with both international and Nigerian laws.” Any deaths or injuries were “the direct result of the illness, and not the treatment provided to patients in the Pfizer study,” the company stated.
...

That "any deaths or injuries ... direct result of the illness" bit bothers me. If the new antibiotic didn't work, then the children died of the meningitis. Yeah. But if they would not have died had they gotten the standard treatment, then maybe they didn't die from the new meds, but they certainly died of the trial.

I need to know what Pfizer considers informed consent, and whether such consent takes into consideration issues of the consenting parties' sophistication and willingness to accept the dictates of authority figures.

Or maybe I just have an overdeveloped suspicion of authority figures.
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