Like millions of Americans, I went to the local movie theater last weekend and watched the world bend in the Leonardo DiCapprio movie Inception. And while the movie didn't leave me with much to talk about, the pre-show Powerpoint presentation did. Mixed in amongst the ads for local eateries and trivia questions, was an announcement for a clincial study of an experimental vaccine against the virus that causes Dengue Fever, a disease which affects tens of millions of people each year.
The people developing this vaccine could be responsible for saving a very large number of lives, and I'd just been invited to help out. I snapped a picture of the slide with my iPhone and gave them a call after the movie.
As it happens, this was not the first time I expressed interest in a study. In the early 1990's while I was a student at the University of Utah, I was a subject in a phase III trial of the drug lansoprazole. You may know this medicine as "Prevacid," which recently became an over-the-counter medication in the US. A "phase III" trial is the last stage of trials before the product hits the market widely. The drug has already been well-tested at this point, but even so, the FDA demands testing on hundreds and thousands of people (at the expense to the drug company) to be as sure as possible of safety. If 1:1000 people have a problem with a drug, that could translate to thousands of problems down the line, so we're all reaping the benefits of this highly scrutinized process.
At orientation I learned that this drug was nearly ready for market, but there were minor concerns over effects on testicle size, seminal volume, and some other things that I don't recall. I had several medical examinations, including EKG's and I was sequestered for a few weekends and required to eat very specific foods so that my metabolites could be compared with the other subjects through carefully timed blood draws. I had 90 in total. And yes, I was asked to provide semen samples and subject myself to testicular calipers a few times. (One odd note... no one was allowed to "help" with semen collection – we were required to "fly solo." Somehow, we all managed.)
We were in a dorm during those sequestered weekends, and we spent the weekend reading, playing pool, and watching movies. Most of the subjects were students like myself. We were being paid $1,000 for our time, and given that we were able to study while sequestered, it was a perfect arrangement for students.
One test subject was not a student. He was, he said, the Messiah, and had come to Earth to redeem the Mormon faith. You may have heard of him – his name was Brian David Mitchell, and 10 years after the study was over, he abducted 14-year old Elizabeth Smart. The story of my interactions with him are for another article.
There was a 50/50 chance that I recevied not the drug but instead a placebo, and I have no way of knowing as it was a double-blind study. I experienced no side effects, and the drug was ruled safe and effective by the FDA.
As I mentioned, this study was costing Abbot, the pharmaceutical company, a great deal of money. Sadly for them, an oversight among the medical staff meant that I did not receive an EKG when I was supposed to, and though I went through the rest of the steps and did get paid in the end, my data and those of a few others were invalidated. I also believe the University of Utah Medical School lost their contract with Abbot over this incident.
I tell this rambling story to encourage people to consider joining a drug trial. There is risk – these are, by definition, drugs and treatments that are unproven. You will be compensated, and if you have a chronic illness, you may receive treatment unavailable in any other way. It's not always a pleasant experience, but you will be doing something that could help alleviate the suffering of countless millions of people. If you're a student, retired, or just have a bit of time (or need for some extra cash) visit clinicaltrials.gov to see if one interests you.
Upon calling the University of Vermont, I was informed that I do not qualify for the Dengue Fever study because I have been previously vaccinated against Yellow Fever, a similar viral infection. I had planned to blog about the experience of going though the trial, but now I'm going to ask you to fill in for me.
Though this article is rambling in narrative, I hope it gets across the idea that a great deal of care and effort is put into the develoment of modern drug treatments. My data was excluded because of a simple mistake, though it's unlikely that the data they missed would have had any impact whatsoever. They paid hundreds of young men $1,000 each to test a drug that had already been extensively tested, and this was just one of likely several phase III trials. If a drug hits the market in the US, you can be assured great care has been taken to show that it's safe and effective.
It's not perfect, but no "ancient wisdom" or "proofing" can compete with the rigorous and laborious testing that modern medical science offers and the FDA demands. And you can be a part of making the world a better place by considering becoming a subject in a trial near you.