Remember how I got spooked into writing HD? How I left an ethics class and was terrified as to the loose way certain future scientists thought about things? That experience birthed Eugene and the entire theme and concept of HD. Here's a real-life example of that inspiration. The story gets even more convoluted here. And that Tramont guy keeps sounding more and more like Eugene. And boy, oh boy, do these articles get the story juices flowing.
After I got over the initial shock of similarity, I started really burrowing into this latest bump for the NIH. First of all, I actually understand a lot of the junk they're talking about, from both the AIDS science perspective and the clinical trial perspective--thanks to my job. That's pretty exciting, especially because the sort of audits that revealed the problems in Uganda is the work that I'm trying to do more and more of here. So it was pretty spiffy to see a direct application of the importance of such work. Second, doncha just love how Tramont can veto all sorts of concerns because he's got four decades of medical experience AND because he really doesn't believe the people raising the concerns could possibly understand AIDS. Aside from the flaming arrogance of that attitude, the implications of such a statement are just thoroughly horrifying as are other ideas expressed by Tramont. And finally, despite all the arguments from Tramont (and I think some other mucky-mucks at NIH) that the science of the study was just fine and dandy and needed to continue, it turns out that the drug confers a resistance to all other similar drugs used for AIDS treatment.
The Tramont-Eugene parallel is really eerie. This man obviously sees the dire need for AIDS treatment in Africa, especially for children of infected mothers. He finds a promising drug, one that there was likely political pressure for given Bush's plan to stomp AIDS in Africa. He sees some good science, some good reasons to get the drug into trials where people really need it. He gets sick of the bureaucratic steps that the FDA requires of anyone wanting to set up clinical trials for a new drug. He pushes a few things here and there, telling himself it's OK because the standards for Uganda human research have got to be different than they are here given the state of technology and living there. And, besides, the research is going to save lives, so push, push, push. Then the research backfires, the pushing is revealed, and it's determined that the pushing may have endangered more lives and perhaps even the NIH and all clinical trials in Africa. The road to hell, man.
This story gives me the creeps. A big shot at the NIH dismissed the opinions of those trained and paid to assess security, health, and regulatory concerns of clinical research because he felt he knew better. A big shot at the NIH altered reports to put a better appearance on troubled research so the Prez could endorse it and visit the sites without scandal. A big shot at the NIH sanctioned the idea that it was OK to have lower standards for health and human safety in clinical trials in a third-world country because the quality of life is so much different (read: worse). Basically, a big shot at the NIH took advantage of a situation and gambled big with the lives of Ugandans already afflicted with a terrible disease. And he lost. Those subjects are now most likely unable to receive any similar AIDS treatment because they're resistant. As if we needed more problems with pharmaceuticals and research and AIDS in Africa. And the NIH and Tramont are adamant that he did the right thing.
Excuse me while I consider removing HD from its very comfortable and concealing trunk and see if I can fix it. I hadn't realized just how necessary that thing was going to be so soon in the future.