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Another Way to Help PDF Print E-mail
Swift
Written by Jeff Wagg   
Friday, 23 July 2010 14:23

dengueLike 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.

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written by daveg703, July 23, 2010
Bravo, Jeff!
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great news
written by live.the.future, July 23, 2010
A nephew of mine (brother-in-law's son) is recovering from Dengue fever. They live in Sri Lanka. It would be great if we could develop a safe and effective vaccine against this disease. Too bad I'm nowhere near UVermont (central IL), I'd love to help out and I could use the $$$ too. :-) Don't know if I'd qualify tho, I got a bunch of vaccinations when I went to Sri Lanka 2 years ago; yellow fever might have been one of them.
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written by HarveyC, July 23, 2010
The other name for Dengue Fever is, "Break-Bone Fever", it cause so much pain it's like you have broken a bone.
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Two Sides
written by Conjur62, July 24, 2010
I agree that there are potential benefits to being part of experimental research. For mankind as a whole, this research is invaluable in terms of developing new medications to treat previously challenging diseases. And the potential benefit to the person participating in the research can be significant in terms of improving their health. As the same time, there are risks involved due to the experimental nature of the research. Certainly the controls that the FDA place on the process mitigate some of those risks, and I would certainly prefer to participate in trials in the US than in some less regulated jurisdictions, but the risks still exist. As with many decisions, there is a risk / reward comparison to be performed!
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written by GeekGoddess, July 25, 2010
Good article, Jeff. Thank you

I wanted to hear about Brian David Mitchell. Did he have three names back then? That's always the sign of a sociopath/serial killer type.
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written by The Central Scrutinizer, July 25, 2010
Was your testicle size affected?
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Some other considerations
written by Todd W., July 26, 2010
If you are interested in participating in a clinical trial, but are nervous about even asking for more information, keep in mind that you can always let the researchers know that you might be interested. Find out more about the study, go over the consent form and ask any questions you might have. If, after all that, you decide you don't want to participate, you don't have to. You can also change your mind at any time during the study and decide to drop out. Consent forms usually spell this out and state that the researchers will make sure you stop safely.

Although I've never participated as a subject (yet), I review trial protocols as a member of an institutional review board and have a keen interest in ethical conduct of human research. While not everyone will directly benefit from participation in a trial, you can be crucial to advancing our medical knowledge.
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I want to do this!
written by MissKitt, July 26, 2010
A year or so ago, I was disappointed to learn that I could not volunteer to catch malaria for the advancement of medical science...I'm too old. My husband, I confess, was relieved because he thought it was "the crazy idea you've ever had" when I told him I was applying.

This would have been a sweet gig: You get your vital information gathered; you stick your arm in the mosquito tube (or whatever the protocol they were testing is) and get bitten. Then, you go home for a few days and then spend a weekend at the study site, getting blood tests to see if you have malaria brewing. As soon as you have confirmed parasites and/or antibodies, they treat you with anti-malarials to kill the disease before you even get symptoms!

The purpose of this study was to determine if the study protocol for infecting people with malaria would work, and how common the infection rate was. Then, later tests of different malaria vaccines would have a valid means of subjecting both vaccine recipients and controls to infection risk.

I commend anyone who helps out with this process, as these insect-borne diseases are the scourge of the tropical world--including, potential, the southern US states. With the banning of DDT, the risk of mosquito-transmitted diseases has risen dramatically.

Good on ya for trying, Jeff, and I encourage those who are allowed to participate to do so.
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Well, I'll be...
written by Griz, July 27, 2010
...Jeff is or was a Utahn, at least for some period of time. I would be very interesting in hearing about your experiences with Brian David Mitchell. All of us in Utah watched the Elizabeth Smart case closely and in my day job I worked with several folks who were part of that investigation.

It needs to be said, though, that no all companies that purport to offer opportunities for participation in clinical trials are on the level. Since word has gotten around about paid participation many scam artists have taken advantage of that and there are web sites out there, similar to the work at home or envelope stuffing scams, that will take your money and at best give you a list of programs you could have gotten yourself, and at worst lead you on trying to get more money out of you. Folks should be encouraged to do their due dilligence when being offered such opportunities, especially if there's a price tag associated with it.
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Last Updated on Friday, 23 July 2010 17:36