Nigerian Families' Claims Against Pfizer Over Drug Tests Reinstated

[Courtesy of Alicia Ouellette]

The United States Court of Appeals for the Second Circuit has handed down a case of major importance in research ethics and international law. The case is Rabi Abdullahi v. Pfizer. The plaintiffs are Nigerian children and their families who were subjected to medical experimentation in Nigeria by drug manufacturer Pfizer. Specifically, the children were among two hundred sick children in Nigeria given the experimental antibiotic Trovan as part of a protocol designed to test the efficacy of Trovan against that of a standard antibiotic treatment. The plaintiffs sought, and won, the right to sue Pfizer in federal court for damages caused by Pfizer's involuntary medical experimentation.

The decision is legally significant for its holding that nonconsensual experimentation on humans violates a legally enforceable norm of customary international law. No American court or treaty recognized such a norm before this case. Not surprisingly, the opinion is not unanimous. The dissent accuses the majority of creating "a new norm out of whole cloth [that] misconstrues – rather than vindicates – customary international law."

The opinion can be accessed at this link: http://www.ca2.uscourts.gov:8080/isysnative/RDpcT3BpbnNcT1BOXDA1LTQ4NjMtY3Zfb3BuLnBkZg==/05-4863-cv_opn.pdf#xml=http://www.ca2.uscourts.gov:8080/isysquery/irla125/10/hilite.

The opinion is long, and includes several technical legal issues. But the court's analysis of whether universally accepted and legally enforceable norms of international law prohibit medical experimentation on non-consenting human subjects (which begins in earnest at page 22 of the opinion) breaks new ground in American law. It is worth reading.

[Editor's Note: For articles that give you more background on the Nigeria vs Pfizer Trovan suits, here are links to few:

http://news.bbc.co.uk/2/hi/africa/6721771.stm

http://news.bbc.co.uk/2/hi/africa/1220032.stm

http://news.bbc.co.uk/2/hi/africa/6719141.stm

http://www.washingtonpost.com/wp-srv/world/documents/Clinical_Trial_Report.pdf

http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.html]

Which comes first, the drug or the disease?

Today's NYT reports that Pfizer has begun direct-to-consumer advertising for their drug, Lyrica. It's not a new medication, having been approved for some time for the treatment of nerve pain (as experienced by some people with diabetes or shingles).

What's news is that the advertisements are for a new indication: fibromyalgia. Fibromyalgia is a condition for which no definitive diagnosis exists, and its cause and mechanisms are not understood by medical science. People who have it, most of whom are middle-aged women, complain of chronic, widespread pain and tenderness, as well as extreme exhaustion.

But whether fibromyalgia really exists is a contentious issue. Those who suffer from fibromyalgia insist that it is a real, and debilitating, problem. Numerous advocacy and support groups exist online and offer individuals the chance to compare notes with fellow sufferers. Skeptics charge that it is essentially a psychosomatic complaint--i.e., "it's all in their heads."

A few features of this story are worth comment (in my view, anyway). One is that we should be aware of the long-standing tendency of the medical establishment to minimize symptoms it can't explain by saying they are psychological--i.e., not "really real," and outside the purview of "real medicine." Many of these conditions (like irritable bowel syndrome, multiple chemical sensitivity, and chronic fatigue syndrome) tend to affect middle-aged women more than other groups. Coincidence? Maybe. But maybe not. Either way, it's worth thinking about whether these issues are being too easily dismissed.

Another is the influence that pharmaceutical companies have in our society over what "counts as" illness or disease. On one view, if there's a drug for it, then it's a disease. Thus shy people may actually suffer from social anxiety disorder and require Paxil; short people might have idiopathic short stature and need human growth hormone; and the list goes on. Is this trend toward medicalization a good thing? What does it mean, in practical terms, when we move a condition from the "some people are like this" (normal human variation) column into the "people who are like this have a disease" (illness) column? Who benefits from those effects?

One more thing to consider: the challenge of pain. As a subjectively experienced phenomenon, it's tough for medicine to deal with. Most medical problems are objectively measurable in one way or another, but pain is particularly tough to pin down. People have different pain thresholds, experiencing more or less pain in response to the same stimulus. It's been the standard view for a while now that women experience pain differently from men, though whether these differences are biological or social (or both) is still unclear. And the data source for pain? We mainly have to rely on self-report--and as a general rule, science doesn't like self-reported data. But the flip side could mean denying needed relief to people who are suffering ... and who wants to do that?