After three long weekends (and 17 days) I learned a lot. Perhaps a little too much. This is what happened. Part One will look at the screening and orientation process.
Three additional parts covering the three consecutive weekends of the trial will follow in separate blog entries. Some of the names have been changed but I kept detailed notes in order to maintain accuracy. All information and research was current in 2008 when this was originally written.
Monday Morning
Today, out of the blue, I agreed to become a medical experiment. Personally, I blame my wife who works at a medical research facility. This company was conducting a study that needed to meet its quota of participants quickly, and I somehow qualified.
This wasn’t the first time I was told I’d make a good research study candidate. A month ago I was informed of a study that paid over $2,000 for healthy men to visit the facility numerous times (over the span of several months, mind you). The researchers would ask questions and poke and prod a little. Meanwhile, the participants would take pills that may or may not be placebos, have their vitals recorded, and, oh yeah, be asked to take an adult magazine or movie from the in-house “Velvet Room” in order to produce a sperm sample in a clear plastic cup during each visit.
I’m not sure of the specific purpose but I imagine the study measured the effects the medication had on sperm production.
Of course, there was another way to look at it: would $2,000 be sufficient compensation for about two dozen self-inflicted orgasms? Hmmm. That’s a no-brainer, except for the fact that it would be a little humiliating to talk to strangers about my ejaculations week in and week out. And, to top it all off, I would be expected to masturbate on demand! That is not exactly a skill I would post on my resume.
From inside sources, I had already heard scary stories about one guy who couldn’t adequately fill up the plastic sample cup and had to go back and try again. Then, there was a case where somebody missed the cup altogether. Talk about a nightmare.
Originally, I strongly considered taking part in that clinical trial. All I could think of was how $2,000 could buy a special custom-made 24-inch iMac with lots of memory, free space, racing stripes and a matching retractable cup holder. Or, I could purchase NBA season tickets. After all, why shouldn’t I treat myself for landing in the cup all those times? Oh, right. The cup. The degradation. The questions. Right, right. That won’t happen in a million years.
The daydreaming abruptly stopped and I went back to my regularly scheduled life until I was told that the site was looking for healthy people to come in for a different study that would involve having a lot of blood drawn, among other things. I’m sure there’s much more to it than that, but my informant didn’t have any details, except that I would have to come in for a screen visit and it pays $1,580.
After daydreaming about a new iPhone, I opted to take the plunge.
Tuesday Morning
It is the anniversary of the terrorists’ attacks on the World Trade Centers and I can’t think of a more ominous day to come in for the screen visit for my first clinical study. The somber mood of the morning has inspired me to reflect on the real impact of being in a medical study.
The way I see it, sooner or later these trials produce medications that actually help people. Nobody has found a cure for cancer, but there are a lot of lifesaving and health-improving medications on the market that had to go through the trial process first. The doctors, the people who performed the studies, and the patients themselves have all contributed to that end. Even the people who took placebos or participated in a study that ultimately yielded unsuccessful results have all helped the process plod along in a positive direction.
I think it was Thomas Edison who said: “I have not failed. I’ve just found 10,000 ways that won’t work.
The goal of clinical trials is to determine if a treatment works and is ultimately safe. Thus, clinical trials often have to find out how things don’t work before they can figure out what will.
There are various phases in clinical trials, each one is a stepping stone that brings researchers closer to placing a new drug on the market.
After surfing online, I’ve learned some background information. According to Wikipedia, Phase I research is the first step in testing on actual humans. At this point in the process, researchers study how the body reacts to a treatment, how much can be given safely, the best way to administer the treatment, if there are any potential harmful effects, etc.
Before Phase I, most studies have been performed on animals or human cells. Since it is the first time the treatment is being used on humans subjects, there is a significant deal of risk involved. However, to cut down on the possibility of harm, researchers start with smaller, more conservative doses which will likely increase if there are no (or minimal) side effects or other complications.
Because risk is ever-present, participants in Phase I studies are limited in number (typically between 20 and 80 volunteers). They often test on healthy subjects because of the potential for problems, but a few Phase I studies focus on drugs for “special needs” patients — those inflicted with an end-stage disease without other treatment options, for example.
Many times, the studies last for several months. Those that survive (I’m talking about the drugs, not the participants) move on to Phase II.
Phase II is about refining the drugs now that they are considered safe. During this stage, researchers test whether the treatment works the way it is intended. The scope of such trials expands to a larger core of people, perhaps between 100 and 300.
In addition to obtaining more preliminary data on the efficacy of the treatment, these studies closely monitor short-term side effects and risks associated with it. Naturally, the clinical trials are controlled and monitored closely as there is still so much to learn about the drug.
It can be a frustrating process, too. Only about a third of all experimental drugs successfully complete both Phase I and Phase II research.
When a drug manages to make it to Phase III, it has shown promise in the previous phases. There is hope. There is potential. At this point, there is a 70 to 90% chance of success.
In order to make sure the results are not susceptible to conscious or subconscious biases (after all, the medications are close to being considered wonder drugs by now), there must be randomization and “blind” trials. Incidentally, this can also be the case in previous phases.
A typical “double blind” study (which tends to yield the most accurate results) is when patients are given a “new treatment” and an “old treatment” arbitrarily. Some will try the study drug; others will receive the current standard treatment at the time. Both the researchers and the patients will be oblivious to which one is which. This way, researchers might not see the results with rose-colored glasses, and patients can’t try to coerce or plead with the researcher for the new treatment since nobody has any idea which treatment is being tested. This keeps the process fair.
Phase III studies are the most expensive and time-consuming. They can take several years and might have patients numbering in the thousands. Grand scale trials make it easier to see how the experimental drug affects everybody with the condition. No two patients are exactly the same, so it benefits the study to have a variety of people to examine in order to see the full spectrum of possible results.
When a drug beats the odds and shows favorable findings at the conclusion of Phase III, it is often time to hit the campaign trail. If a researcher feels there is significant medical importance in his data, he or she may try to get the results published. Those findings will undergo a peer review by other medical experts.
If there is a positive consensus on the drug’s capabilities, then it is time to submit an application to the industry’s Godfather — the Food and Drug Administration. It is up to the discretion of the FDA whether or not an experimental treatment can be considered acceptable to the general public. The FDA can approve or deny the application, or it may rule that further studies are merited and order the drug to go through a Phase IV study — perhaps it needs to be tested for interaction with other drugs, for example. It’s an important decision, and, yet, time is always of essence.
Let’s say Exhibit A is a drug designed to treat patients with metastatic or unresectable soft tissue sarcoma. As a drug used in chemotherapy, it could potentially stop the growth of tumor cells by killing them or preventing them from dividing.
You can damn well bet that cancer patients with metastatic sarcoma in their lungs want Exhibit A approved now so their next chemotherapy treatment could halt death in its tracks. You can also damn well bet that no doctors want to give Exhibit A to their patients if it can likely do more damage than good. They want to be sure it won’t make things worse.
It’s not an easy decision, especially with the clock ticking. For this reason, the FDA grants top priority to drugs that have the potential to treat a life-threatening condition. Regardless, the agency tries to rule on every new drug applicant in less than six months.
To the government, that’s rushing things as fast as they dare. For those suffering, that is an eternity.
With that in mind, I feel quite silly for being enticed by $1,580.
*************************************
This morning, I took part in my screening orientation with another potential participant I will name “Steve.” This will be a Phase I open label clinical trial, which means there are no placebos.
The drug they are evaluating is a slightly modified version of one that is already on the market. It treats people with cardiovascular diseases. The drug company sponsoring the study hopes to escalate its effectiveness.
I have been informed there is nothing to worry about with the new version. Over 350 patients have been tested with 1,500 mg of the drug with no visible side effects. Whew.
Then I am informed that, nonetheless, there are still potential side effects: diarrhea, nausea, sleeplessness, shortness of breath, vertigo, constipation, etc.
In a few rare instances, there is a potential for more severe side effects: heart attack(!!!), kidney stones, bleeding in the brain— say what?
I stopped hearing everything after that phrase. What is that? I mean, I know what it is. It’s probably exactly what it sounds like, but shouldn’t something like that only be caused by a blunt object being slammed repeatedly against your skull? What the Hell is in this pill? Dynamite?
I decide to start listening again.
Those who participate in this study must meet a few requirements. While subjects can be of either gender, they must be between 18 and 55 years old and have a BMI (Body Mass Index) and blood pressure that fall within certain parameters.
Smoking is not allowed during the duration of the study, as well as two weeks prior. Additionally, candidates must not have abused alcohol or drugs in the past 12 months. Those who have donated blood within eight weeks are also marked as DNQ (Did Not Qualify).
One interesting restriction is that the study will not accept anybody who has been in a clinical research trial in the past 30 days. This sparks my curiosity. Are there really clinical trial junkies? I’m not talking about the unhealthy people who truly need hope. I wonder if there are healthy people out there who purposely play the role of guinea pigs over and over again.
For now, I’ll just try to get through one study. In addition to this initial screening visit, which takes about two and a half hours, I will be required to come in during the next three weekends. By that, I mean arrive at the testing facility at Friday at 6 p.m. and remain there until about 8 or 9 a.m. on the ensuing Monday morning.
That’s over 180 hours of my life (more than I worked in all of last month) spent in a medical testing facility. That seems a bit insane.
At any rate, this particular site is 21,000 sq. ft. with about 80 beds in its dorm-like accommodations. The quarters are cramped and the beds are small with hard mattresses (I have chronic back pain, unfortunately). In each room, there are three bunk beds and absolutely no open or wasted space.
By the way, each of us will be rooming with somebody of the same gender. Steve seemed relieved of this fact. His wife would have a “big... really big” problem if he had to share a room with a female participant.
The reason the facility has so many beds, and why we have to stay for three consecutive weekends, is that the researchers need to monitor us closely and make sure we adhere to our various restrictions and schedules. That makes sense, sure, but it does not sound like my idea of a good time.
During our luxurious stay, we will be popping pills. Some will be the old medication. Some will be a new version of it. Sometimes, we may take both. They want to see how our bodies absorb and metabolize the medication. While in the facility, our diet will be completely controlled.
They will tell us what we can or cannot drink and they will provide meals of their own choosing. There will also be times when we are are not allowed to have water for a limited amount of time.
When we check in each Friday evening, we will have to obey several rules. For 48 hours prior to our arrival, we are not supposed to consume any alcohol or caffeine, and we are not allowed to take any medications during the entire period of the study. So, if my back acts up or I get a headache from caffeine withdrawal, I’m out of luck.
Actually, that is not entirely true. I can take medicine but then I have to report it. It could amount to a study deviation (which must be noted in the study), or worse, a protocol violation (which means I might even be removed from the study).
One thing I find amusing is that when we check in, we’ll only be allowed to take certain belongings. The following is a partial list of contraband items: no food (including candy, gum, tic-tacs, mints, etc.); no medications; no water bottles, cups or jugs (empty or full); no weapons of any kind; no musical instruments; and no large sums of money.
I can understand that they’ll check us for medications, food and candy (apparently, tic-tac is not a candy, gum or mint, but instead, deserving of its own categorical mention), but the “no weapons” clause baffles me. I totally support this localized weapons ban, but I wonder what happened that lead to this rule’s creation.
I’m also amused that we cannot have large sums of money. Are they worried about patients bribing employees for candy or beer? Perhaps they fear copious amounts of cash will lead to theft, gambling or other ill-advised ventures.
I suppose if you put a group of strangers together in close quarters for two-and-a-half straight days, there is bound to be some kind of bloodshed or political struggle. Hopefully, these rules will prevent that.
As another aside, we are also not allowed to bring in any hygiene products. They will be provided for us. I know there must be a good reason for this, but I cannot fathom why.
Fortunately, there are many things you can bring in with you, such as a laptop (they even have wireless Internet), an mp3 player, books, magazines, puzzles, our own pillows and blankets, and cell phones (provided they do not have recording capability). This is to prevent industrial espionage, I assume.
When it comes to occupying ourselves, most of the patients will rely on the recreation room, a.k.a. the Day Room. I have a feeling it will provide salvation for us on the long weekends.
The Day Room is a very large open room built with one purpose in mind: entertainment. It boasts a pool table, a huge widescreen TV with tons of comfortable-looking recliners and chairs set up in movie theater formation, and, for good measure, there’s another huge widescreen TV on the opposite end of the giant room. Those who do not want to watch cable TV or DVDs can take advantage of an arcade-style video game near one corner, or browse through a shelf full of books, games and puzzles that covers up almost an entire wall.
Of course, all this talk about what I will be able to do on the weekends is jumping the gun. I have to be approved and admitted in the study first. So far, I’ve just signed papers — a lot, in fact. We shuffled through 15 pages of small print legal copy and filled out another 13 pages of medical history.
Every aspect of the study is explained to us in full, then they review our medical histories. Steve and I do not have any questions at this point, so we are lead to the Conduct Room for testing.
Maybe “room” isn’t the best name for it. It’s the size of about four or five rooms. There are several hospital-type beds along one wall, stations for drawing blood, and numerous other machines designed to measure and record all the vital numbers in the human equation.
A man in black scrubs tries to determine if we have the right stuff to proceed. He jots down my weight (which looks much better when read in kilograms as opposed to pounds) and measures my height. He also takes my temperature and blood pressure.
Next, I must provide a urine sample. Ah, the fun has truly begun.
Given, a urine sample is much less intimidating than some other types of samples, but there’s something intrinsically odd about being handed a cup and pointed to the bathroom. I feel like a major league baseball player.
I notice that the patient number on the cup is 13. Another ominous omen? Now, I’m just freaking myself out.
After Steve finishes, I step up to the porcelain plate. The directions on the wall tell me: “Clean head of penis” with a sterile wet nap before I collect the sample. I am also to make sure I do not contaminate the sample cup by allowing my fingers to touch the inside of it. Oh sure, the inside of the container is good enough for urine, but not my fingers. That ends up being the strangest part of the day. The second strangest part directly follows. It’s time for the ECG (electrocardiogram). The only reason this step is so weird is because the black-scrubbed gentleman has to shave parts of my chest. It’s a little embarrassing, but I am wise enough to be grateful.
After that, Steve and I head to the lab station so they can draw samples. Steve has veins that pop out everywhere like bright neon billboards saying “Open All Night.” My veins, as usual, stay hidden under an unlit “No Vacancy” sign. They require encouragement. Still, the whole process ends up being over in a few minutes and virtually painless.
By now, Steve and I have bonded a little by going through this surreal scenario together. He tells me he is doing this for the money. He’s a home remodeler who has had difficulty finding work in an economy where nobody can afford to buy or fix up houses.
Compounding matters for him and his family (including three children), his wife is a realtor who had to put her license away and become a stay-at-home mom. For now, it’s cheaper for her to stay home than to try to sell houses.
Steve is undergoing this ordeal in order to “supplement” his income. When he says supplement, though, I get the feeling it might be more than that. He smiles uneasily. I can tell he’s going through an immensely difficult time. He’s doing whatever he can to help his family.
I, on the other hand, am a shallow, Hell-bound person, certainly. Sure, I have had my own share of financial stress of late, but I was enticed by the prospect of iPods and floor seats.
Now, I look at Steve and feel very foolish. And lucky.
After finishing the various tests, Steve and I are lead to separate exam rooms. This is the last I will see of him unless we both make the study. I won’t know until Friday, but I really hope he does. He’s an interesting guy with a good sense of humor. He was able to instantly transform the initials on the various sample cups in the Conduct Room into celebrity names. Usually, it is a rock star. (EVH = Eddie Van Halen. SRV = Stevie Ray Vaughan.)
After a short wait, a doctor the size of a Chicago Bears’ defensive lineman comes in to ask me a few questions and scrutinize me. The man could be intimidating without even trying, but as soon as he opens his mouth I realize he’s probably the nicest doctor I’ve ever visited. Why aren’t there more doctors like this in the world?
The exam is quick and easy. He listens to my heart, checks my ears and throat and pushes on my liver and stomach to see if I feel any pain. That’s it. I am done. My first visit is over. I will find out in two days if I should pack a bag and be ready to come in on Friday night.
Continued in Part Two...
Posts
No comments:
Post a Comment