After three long weekends (and 17 days) I learned a lot. Perhaps a little too much. This is what happened. Parts One & Two already covered the screening and orientation process and the initial extended visit. Now, Part Three focuses on the second weekend of the clinical trial. One final part will follow. All information and research was current in 2008 when this was originally written.
Second Friday of Study
I checked back in at 6 p.m. for my second weekend getaway. This time around, everybody knows each other and there is a greater degree of comfort. When Ron arrives, I ask him about his big test on Monday. “I think I only missed six,” he says.
Earlier in the week, I was called by an employee from the facility. It seems I was the only patient with a protocol deviation, or a change or departure from the study’s procedures.
Drugs are usually the problem, and I’m no exception. At least my discrepancy was not due to illegal ones, but, rather, over-the-counter pills.
When I filled out my paperwork, I didn’t indicate the stop date for some medications that I take occasionally: Zantac (for indigestion); Ibuprofen (for headaches); and Naproxen (for muscle inflammation). All of these drugs are things I take as needed, but they needed to know if I had taken them within a specified period prior to the study. I hadn’t, so everything is still OK.
During the medical procedures tonight, I was asked if I had experienced any adverse events during my week out in the real world. Unfortunately, I had, and I was not the only one. Vida had experienced two minor “butterfly” flutters in her heart. They only lasted a few seconds. Me? I had headaches for the past three nights, and I can already feel another one forming again. They are not too distressing and I did not take any medication for them, but it all must be noted nonetheless.
I am informed that if I need something for the headache tonight, they can contact the on-call doctor and he can prescribe something. I imagine taking a medication will mess with the protocol somewhat, although I am sure that kind of thing happens often.
Speaking of side effects, while we played a round of pool, Brad asked me if I had felt any. I told him about the headaches, which concerned him. Then, he mentioned to me: “I have a couple of red spots on my ankles. They could be a side effect.”
They could, I suppose. They could also be ant bites. Of course, I’m sure it’s better to side with caution.
Second Saturday of Study
I woke up at 5 a.m. I had to get out of that bed.
I believe we have another ten blood draws on the itinerary today. I do the math and figure that, from start to finish, we will participate in approximately 40 blood draws, 24 in-house meals, nine sleepovers, five urine samples, three alcohol tests, and a partridge in a pear tree.
Clearly, my mind is still hitting the snooze button.
Early, it’s quite a mix of people. Some of the teen smokers are back, as is Roger, so the ages represented are all over the map. I ask Roger about his health and he says he feels very good. Apparently, that hasn’t been the case in the last few days.
“That’s how it goes,” he sighs. Even though it’s a good day, it could mean nothing. The treatment could be working, or, just as likely, it could simply be he’s having a good day.
He’s ingested his fourth dose of medication and won’t really have any idea of its effectiveness until he has an MRI again at the 30-day point. “I don’t know if it’ll do me any good,” he says of the medicine, but that doesn’t mean he will give up: “If it doesn’t work, maybe we’ll find another one that does, before it gets me,” he smiles.
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As we filed in for our first blood draw of the day, I spoke to “Fernando,” who is also in the heart medicine study. He is a furniture maker who works with metals and wood. When he walks out holding a cotton ball in the middle of his bent right arm, he smiles a mischievous grin and says: “Breakfast for me.”
Today, Fernando is a winner of the breakfast lottery. Last Saturday, only two lucky souls got to eat breakfast. This week, there will be four. I assume the remaining three will get to eat next Saturday while the rest of us starve. I say “us” because I’m also a lottery winner. Jordan greeted me by saying: “Today is your lucky day.”
After taking four more white pills, I am asked to open my hands and mouth (and lift my tongue) to prove that I did, in fact, take the drug. Once finished, I only have a small window of time to eat two eggs, two pieces of wheat toast, potatoes and two pieces of bacon. Then, all four breakfast eaters have vitals recorded before going back for more blood draws. Everybody walks back and forth to the Conduct Room all morning long.
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While bored between blood draws I go online to find out what the first medical study entailed. From what I’ve ascertained, it was one conducted by James Lind in 1754. He demonstrated that citrus fruits cured scurvy, the vitamin C deficiency disease often found in pirates and seafarers whose meals rarely grow on trees.
Apparently, a group of sailors who suffered from the affliction were given oranges and lemons for six days and fully recovered from. Wow, that’s efficiency.
These days, I have read, it may take some drugs (such as a cancer-fighting medication) eight years to be approved — and that’s just counting the time it takes to undergo its various research and application processes. One reason cancer drugs are problematic is that it usually takes several months, if not years, to see if they have an effect on a person. Also, it could take a while to find enough participants who meet all the prerequisites of the trial.
That’s not even the entire journey of the drug. Before drugs can make it to the “experimental” status at the beginning of the phases of research, they have to first be discovered, purified, characterized, etc. That all must happen before any tests are conducted in labs on human cells or animals. The process often takes several years, as well. So, conceivably, a drug can take over a dozen years from inception to commercialization.
It is also interesting to note, that most drugs don’t make it to the clinical trial stage. In fact, approximately 1,000 potential drugs are tested before just one of them reaches the point of being in Phase I of a clinical research trial. Even Rocky Balboa himself would balk at those odds.
Of course, those who bet on an underdog like Rocky stand to win big. The same is true of the drugs that go the distance. The amount of money involved in medical research study is astronomical because thousands of drugs fail for every one that succeeds. Yet, when a drug makes it to market, the financial compensation can be absolutely mind-numbing.
According to a survey by the Agency for Healthcare Research and Quality, the most successful prescription drug domestically in 2004 — when measured by sales — was Lipitor, the cholesterol-lowering pill. Americans spent more than $9 billion on it that year. That’s just one drug, and that was almost four years ago. More recent figures are hard to come by.
Cholesterol drugs were the big seller of 2004. The second highest selling prescription drug on the market was also classified in that category. It was Zocor, and it flooded the market with $4.7 billion in sales.
Stomach acid-fighting pills comprised a large portion of the domestic prescription market three years ago. Drugs such as Nexium tallied in $4.2 billion in 2004 and Prevacid took in another $2.4 billion in the same year.
Those drugs may make the biggest sales splashes, but they are only drops in the overall bucket. Prescription drugs have become excessively expensive and are a major reason why American healthcare costs have spiraled out of control.
According to statistics located on the National Coalition on Health Care’s web site, domestic healthcare reached $2 trillion in 2005, and that figure is expected to increase to $2.9 trillion in 2009. At the current rate of growth, Americans may indeed spend $4 trillion by 2015.
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I don’t care who you are, this schedule will get to you, especially when you are away from home for a span of 60 hours. It’s not difficult, on one hand, because we’re not asked to do much except eat certain foods at certain times and be readily available for the blood draws. Yet, it’s mentally exhausting being in the same building for hours on end knowing that you cannot leave.
Adding a touch of irony to this weird situation is the fact that other participants are mesmerized as they watch a reality TV marathon of a show called Solitary where people compete to see who can stay in a room by themselves the longest while undergoing various hardships and cruel conditions. This does not help the situation much.
Fortunately, my wife and other family and friends visited me for several hours today, which helped quite a bit. Still, it’s been an excruciatingly long day.
I can see some of the others are tired, as well. Brad, dressed in a Pink Floyd “Dark Side of the Moon” shirt, has played pool for several hours and looks like a zombie on Prozac. Many players have come and gone, but he keeps playing, saying in a monotonous tone: “I’ve got nothing else to do.” The boredom has gotten to him enough that he accidentally put pepper in his decaf coffee earlier today.
Currently, he’s playing pool with “Paulo,” a tall teenager whose pants seems to hang down somewhere around his ankles. Paulo is definitely here for the money. He spends most of his time on the video game console or surfing My Space on the public computer.
On the first Saturday of the study, Paulo was one of only two participants who got breakfast that weekend. Within 20 minutes of eating the meal (which is, by no means, small), he asked when lunch would be. He was still starving. Every day he asks employees here about the food schedule and what we’ll be having. We ran out of food last weekend, partly because eight of the nine patients are men, and partly because Paulo has an endless stomach and has no qualms about taking more than the pre-designated portions.
Honestly, I don’t know how he survived this morning when he realized he would not have breakfast today. His first food since 9 p.m. last night came after 12:15 p.m. this afternoon. He looked like he crossed the Sahara with only a dixie cup of water and a pack of tic-tacs. He’s a bit punchy today, as I’ve seen him hit the cue ball off the table nine times now. I started counting officially at the third time as I figured a pattern had begun.
Scratch that. He just made it to double digit territory.
The ball flies across the room and narrowly misses an innocent bystander who is reading. An hour ago, he missed a female teen smoker by about six inches. Before that, the ball took off and rolled hard across the floor over 25 feet away and collided with a hollow, metal table leg.
That cue ball is going to eventually hit somebody and that will be the spark that sets this place on fire. I’m absolutely sure that all nine of us will not make it out alive this weekend.
Second Sunday of Study
This morning, I passed the time away scouring through this facility’s medical brochures in the front lobby. One is looking for Lupus patients. When I ask an employee about it, I get an ominous answer. “We’re not doing that one now. It’s on hold,” she says. “The monkey died.”
The list of other studies is impressive: Alzheimer’s disease; diabetes; epilepsy; seizures; arthritis; Multiple Sclerosis; high cholesterol; obesity/hypertension; restless leg syndrome; and many others.
In addition to these ailments, there are studies looking for people who suffer from mixed bipolar disorder and schizophrenia. I notice how carefully the ads are worded. For example, the bipolar study tells people what they can expect if they participate: “Professional medical examinations, and study drug; Lab results and other information about your health; Compensation up to $4oo for time and travel.”
A clinical trial should not promise to cure an ailment, nor should it offer an inordinate amount of monetary compensation. The reasoning is simple: people should not be financially coerced into partaking in a study or trial.
I know, I know. I realize that most people who take part in healthy medical studies do it for the money, especially the participants in this one.
With that said, let me say that nobody here is really trying to take advantage of some get -rich-quick scheme. When I spoke to Vida about the dozens of studies she’s participated in, she mentioned that the extra income was nice. However, it was never essential.
Money is not the only reason she goes through these ordeals. She truly believes she is making a difference.
Vida figures her life is well spent this way. Her children are all 18 and older now. She’s no longer a full-time mother, and she does not have a full-time career. Instead, she has found another way to contribute to society and to her family at the same time.
I am still a bit skeptical about the whole process. If you pay people money to act as human guinea pigs, then, yes, people are doing it for the money. Yet, that’s only because very few people would participate in a study like this one if there was no financial compensation. It’s just too much to give up. Not paying for so much time would be unreasonable.
I spoke of the easy money before I started this study, but, the truth is, I won’t be going out on a spending spree with it. It will help out, sure, but it will also be hard-earned. I truly feel a sense of pride in working for it.
I’ve tabulated how many hours I’ve given up, and I realize that I’m worth (hopefully) much more than between $8 and $9 an hour, which is what this all works out to be. I can probably make more with starting wages at the In-and-Out Burger.
When it comes to paying out money, research studies face a slippery slope. To avoid unethical practices, the general rule of thumb is that research subjects may be reimbursed for their time and effort provided that amount is not high enough to entice people. So, it should be worth your while, but it should not be a sole means of income.
According to the Partners Human Research committee’s web site, there are certain suggested guidelines that dictate how much money to pay to research subjects. The chief determining factor is how much time is involved. A simple blood draw visit from volunteer subjects may be worth $5 to $25 from the medical research site.
An outpatient visit may be worth $20 to $75. In addition to time, other details may factor in: inconvenience, discomfort (please fill up the cup) and whether or not medications are taken.
The price paid to participants goes up as the procedures get longer and more invasive. Hence, it could be worth $100 to $200 per 24-hour stay. Everything is, by theory, relative. However, if clinical trial sites were to offer $10,000 for a brief, high-risk study, then that would be considered coercive as people would be willing to put their own health at risk simply for a big paycheck. Whereas in this study, patients may want the money, but it won’t be enough to quit their day jobs over. Nor will it be enough to jeopardize their health. If the element of danger was greater in this study I am in, I sincerely doubt any of us would have signed up for so little money.
Of course, not everybody even gets paid for their time. Roger mentioned that he is only being paid for his mileage in his current study. Though the amount is meager, he still views it as worthwhile because he hopes the study will provide a few medical benefits.
What I find really hard to believe is that there is a group of people out there who participate without financial or medical incentives. Some actually do this out of a sense of altruism. They are the type of people who probably have reserved box seats in Heaven, and deservedly so.
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I figured last night I’d hit an all-time low writing about pool ball miscues; today, I am longing for that much excitement. Paulo has (temporarily?) retired from his erstwhile billiards career, so there are no shouts of “incoming” as people in nearby chairs dodge a heavy white ball that flies furiously towards them.
People spend a lot of time upstairs in their rooms sleeping. Many didn’t even want to trek to the second floor to rest their eyes. Some are nestled in blankets in front of blaring TVs, oblivious, off in dreamland somewhere.
At this point, we just keep to ourselves, putting our heads down and plowing through our time served.
Second Monday of Study
The finishing line is still far enough away not to focus too much on it. I imagine next weekend will be easier knowing it’s the final one. For now, however, we must simply trudge through. Even Brad has lost all of his concerns about side effects. He’s more worried about whether or not the jigsaw puzzle he started putting together will have any missing pieces. He keeps talking to the box: “You better have all the pieces in there.”
For some reason, I thought being a real live medical experiment would be more exciting. For healthy subjects, that is not the case. However, I keep thinking of Roger, who had a bad morning today preceded by a restless night. It was too painful to lay on his side and he could not find a comfortable position. For him, this is plenty exciting, but not in a fun way. It is literally a life or death matter.
You could not tell by looking at him, though. He smiles every time I see him. Occasionally, I see the exhaustion seep into his eyes, but he clings to the positive, the hope. That is, after all, why he is here.
Continued in Part Four...
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