Clinical trials are necessary, but who wants to be a guinea pig? Who wants to take a new chemical formulation that has only been tried on rats and monkeys? I'm far from a rat, despite what some people have said. And while I'm just a few genes away from being a monkey, the thought of being in a trial can be scary.
It is a difficult decision, but if we want to help each other and give medicine a chance to advance, clinical trials are necessary. Participants of clinical trials may be tomorrow's heroes.
Oddly enough, with all my paranoia, baggage, skepticism and distrust of authority figures, I entered into a clinical trial. The main reason I entered this study was financial. Clinical trials often mean free medical care. I also had a good relationship with my doctor at NorthStar Healthcare and trusted his insight enough to get over my doubts and jump into the research pool.
He also told me that this new drug had no side effects. Naturally, I didn't believe this for a second, but I had nothing to lose except my T-cells.
There are a million questions that rush through your mind when thinking about entering a clinical trial. What is this chemical? What are the side effects? Am I willing to deal with them? There are side effects the drug manufacturer knows about, but one of the reasons for the trial is to see what other side effects may occur.
Then there's the compliance component. Am I willing to come to this clinic or doctor's office as often as the protocol demands?
Then before you begin the trial they must be sure you are a good candidate. This may mean a million different things depending on the study. Are you treatment naive? Is this your first or fourth regimen? Are you the correct gender, age and weight? Are you healthy enough? Are you sick enough? Qualify, qualify, qualify.
And then once you qualify, you must sign the paperwork. This was the only part that made my legs quiver because within all those documents you are signing there is one that says something like, "If I drop dead due to this study I will not hold this doctor or this company liable for my death." So you have to swallow, take a deep breath and realize that hopefully the odds of this really happening are very low and this is just part of this marvelously litigated nation.
After you have signed your life away you have much blood drawn, and after these results come back, you may be lucky enough to be chosen.
What cinched it for me was that I needed a new drug and here was the promise of one at the right price with no co-pays and free blood work and doctor visits. My current regimen had run its course, my viral load was climbing and my T-cells were dropping. I needed a third drug in order to beat down the virus and get up-to-date with the latest in HIV therapy efficacy.
So here comes this flat, round, chalky white pill without a name and I start to take it, as prescribed, twice daily.
The first three months I walked in there and the research technician took my vitals and asked me the same questions over and over. This was followed by an inspection of how many pills I had taken, literally. The tech would take my bottle and walk away and then come back always happy with me because I was 100% compliant.
After three months I was given a new batch of pills and told to stay on the regimen and not change a thing. The pills were now oval shaped and a pretty light blue. Within approximately six weeks my blood work had come back and my viral load had gone undetectable from somewhere around 120,000 copies and my T-cells soared to almost 400 from nearly 200. They didn't have to tell me that when the pill changed shape and color I had started on the real stuff.
The drug was Viread and my skeptical self could not believe that I had not experienced any side effects.
Not only has Viread proved to be effective as an antiretroviral drug, but Gilead Sciences reported huge profits this year based on the drug's position as the fifth best-selling HIV antiretroviral drug in the U.S.
When someone is on a placebo like I was initially and the researchers find the drug is working, they will switch the patients from placebo onto the real drug as soon as they can because it would be unethical not to. This is why clinical trials have come full circle to a trusted and respectable way to go about helping science, yourself and your community.
If the trial comes to a close and the drug is not yet available on the market, in most instances the drug will be supplied to you so you may continue this new regimen. In a clinical trial you get exceptional treatment from doctors and support staff that want you to be pleased so you will stay the course and the trial will truly be a success. Nobody wants dropouts because the data is then skewed. You receive free medical exams, laboratory tests, and a drug that is not yet available to the general public.
You may even get success.