After three long weekends (and 17 days) I learned a lot. Perhaps a little too much. This is what happened. Parts One, Two & Three already covered the screening and orientation process and the first two extended visits. Now, Part Four focuses on the final weekend of the clinical trial. All information and research was current in 2008 when this was originally written.
Final Friday of Study
Earlier this week I got another reminder of how harshly the public views the medical research industry. It was during a phone conversation with my mother. Apparently, she had mentioned to my uncle that I was in this medical study and he responded by asking, “It isn’t that AIDS' study, is it?”
He was concerned that medical researchers had infected me with the HIV virus. Admittedly, I had no idea what he was talking about, so I Googled for more information.
Recently, the brakes were put on a major international Phase II study sponsored by Merck (whom I swear I am not gunning for) and the HIV Vaccine Trials Network (HVTN). It involved an experimental AIDS vaccine. It was the first study in a new direction researchers are attempting to halt the disease in its tracks. Apparently, the line of thinking is that if a person’s white blood cells can be trained to attack other cells that have been invaded by the virus, they can either prevent HIV infection, or at least acutely limit its scope.
It sounds good on paper, but the first major test was deemed a failure. In the study, more than 3,000 uninfected volunteers had been injected with one of three shots. Half were assigned the study vaccine and half were administered a placebo.
Recently, an independent board, which monitors and regulates clinical trials to ensure safety, did not like an early trend spotted in the data. Shockingly, 24 people who received the actual vaccine developed HIV infections. That number was larger than the 21 placebo-injected volunteers who also became infected.
Perhaps more revealing were the results of a smaller group of participants who had received at least two injections before the study was cut off. Among them, 19 infections were found in those given the real vaccine, contrasting sharply to the 11 infected who were given the placebo. The statistical anomaly is alarming, certainly, and it was the proper thing to stop the study. However, those numbers are not necessarily direct proof that the researchers infected the volunteers with HIV.
You wouldn’t know that if you read the headlines or asked the general public. Many believe the researchers essentially infected the participants. There is no conclusive proof that is what happened, but people maintain a propensity to view medical research with a suspicious eye.
The story is tragic on many levels. I can’t imagine how the 24 people who were given the vaccine feel. They go into a study that is supposed to ward off the “HIV” virus and end up contracting it. How? I have no idea as I don’t know all the information. Did they engage in safe sex? Did they avoid any behaviors that would make them at-risk for HIV? I ask these questions because 21 people who were given a placebo also contracted the virus. How did any of these people get it? The articles I have read do not say.
Based solely on the general study results published in the news, it is impossible to make an accurate and fair assessment of the situation.
Regardless, the entire story naturally makes me even more skeptical of the industry, but not so much that I’m going to run screaming from this study. I would lie if I said I did not immediately think: what if the pills I’m taking in this study caused me to have a heart attack? I would be enraged beyond belief.
As sad as the news is for the people recently infected with HIV, the news is even bleaker for the world. According to statistics from the United Nations, almost 40 million people in the world were infected with the HIV virus in 2006. More than 25 million people have died of AIDS since 1981.
Merck had been testing the drug for ten years. If the vaccine had worked, it would have been hugely important for the global effort against AIDS. After all, nothing is more effective in combating disease than prevention.
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As I check into the facility for the third and final time, I immediately realize this weekend will be different. We are at full capacity. There are 22 of us altogether, almost twice as many as we’ve had sleeping here in the past two weekends.
We gained two more participants for the heart disease study (they are part of a different group), as well as seven diabetics in a diabetes study. We’ve been given clear-cut instructions not to give any of our food to the diabetics as they are on a strict diet that does not include many of the things we can eat.
When we are told our evening snack is ready, we must eat it in the kitchen (far away from the Day Room) to make sure carnage is avoided.
Actually, I’m not joking. I overhead one diabetic say (only half-sarcastically) that he’d kill for a jelly donut. When he said that, one of the teen smokers was eating a jelly donut (a treat he was given for behaving so well). The 14-year-old kid looked quite worried and ate the snack in about three bites as his eyes darted back and forth all around him.
Meanwhile, I write to keep my mind from the fact that I have a huge, throbbing headache. I’m not even sure that this pain is related to my study participation. It feels like a migraine (which feels like an axe wound), something I get about five times a year and haven’t gotten in many, many months. Judging by the severity, it has to be one and the timing could not be worse.
My wife brought a Maxalt (three cheers for Merck who got it right THAT time!) in for me to take, and the study manager informs me that I can take whatever I need to for the pain. Of course, if I do take it, it will have to be documented.
I am already familiar with a mild adverse event. When I had four nights of headaches a little while back, that’s how the researchers classified them. An adverse event is any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medical treatment. It does not matter if the adverse event is believed to be directly related to the treatment. It has to be noted regardless.
There are many levels and types of adverse events. The most serious one, of course, is death. That would be classified as an SAE (serious adverse event), as would anything that required hospitalization or was considered as life-threatening.
Again, when somebody dies during a study, that doesn’t mean it’s a result of the testing. If I had gotten run over by an 18-wheeler on the way in, it would be an SAE.
With a severe, mind-splitting headache, I’ve upgraded from mild, which means the adverse event I’m experiencing is enough to completely interrupt my usual daily activities and require treatment. The question is, what treatment do I take in order to get rid of this useless headache that I can’t help but think feels EXACTLY like bleeding in the stupid brain!
Here’s the dilemma: if I take migraine medicine there are two factors to consider. First of all, I’m taking part in an experiment and I’m supposed to be drug free so they can directly analyze and record what is happening in me during this testing process.
If you start adding other medications to your body, it has the potential to contaminate the findings. There is no way that taking a medication such as Maxalt (as much as I love it) would not change what is going on in my body. In my opinion, that would serve to undermine the last two weekends of my life as researchers would inevitably be dealing with testing circumstances that are far from ideal.
On a personal note, I believe this is an issue of integrity. I signed up for the study hoping to record it in all of its glory. I want to think that this study will end up helping others and I firmly believe that I won’t be helping them as much by taking that sweet little pill. Yes, my head hurts, and it’s unbelievably tempting, but I don’t want to have endured the last two weeks for nothing.
Then, there is the other reason. Let me stress the fact that nobody has told me I’d be in danger if I took another medication. However, if I did, I’d be mixing two medications that have never been combined before. It’s possible they could cancel each other out or not affect each other at all. It’s also possible that they could be a dangerous combination, causing an unfortunate reaction (i.e. brain bleeding, brain bleeding!). This is precisely why medical research has so many phases.
So, after vacillating back and forth many times, I’ve opted to just put an ice pack on it. That helps, certainly, though it’s hardly a permanent solution.
I am determined to go through this last weekend without any caffeine, alcohol or non-study related medications.
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I have not been the most social person tonight, but I have tried to distract myself by talking to some of the newbies, I’ve learned that an employee of this site will be one of the two new participants in our study. “Mario” had to sign a waiver in order to do so.
He is looking forward to the experience because it will help him understand what patients go through -- especially the overnight ones. He thinks his new perspective will help him perform his job better.
Earlier, I said a diabetic man was willing to kill for a jelly donut. That same man was on the phone for about a half hour. I couldn’t help but overhear him.
Apparently, “Scott” just got released from prison before he began the diabetes study. Once he is off the phone, I find out he has five kids and eight grandchildren. Six of those grandchildren belong to his 20-year old daughter. Each of those children have different fathers, he says.
His oft-pregnant daughter is in Louisiana currently and needs rent money quite badly. He can’t leave, nor does he have the money to help her at the moment. Instead, she is supposed to ask her uncle for it and let him know that he will be paid back with the money Scott will receive from this study when it’s over.
Final Saturday of Study
I managed to sleep some, though not for long. With so many patients here this weekend, I now have two roommates. It’s very cramped, and the headache alone would normally be enough to keep me up. However, I am also cognizant of the fact that there are two other people sleeping a few feet away from me, and they can probably hear every creak my bed makes (in the dead silence here) whenever I try to shift into a more comfortable position.
If you do not like sleeping a few feet from a pair of strangers, then you probably don’t want to shower a few feet away from them either. That is the reality here. There are men’s showers and women’s showers.
The men have three small showers in the shower room. They each have a curtain and there is another curtain you can roll in front of the door to afford a little more privacy. So far, I haven’t showered at the same time as anybody else. I chalk it up to good timing. However, I would probably feel a little weird if I walked in the shower room and there was somebody already in there.
It all depends on your tolerance level, I suppose. More people might be annoyed with the facility's four ounce plastic bottle of “All-N-One” whose chief ingredient is water. It claims to be shaving lotion, shampoo and body wash. I’m not sure it can be adequately classified as any of those, but it does manage to make you feel a little cleaner after a shower. I’ve given up trying to shave with it. So, I’ve gone razor-commando on my face for the weekend.
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I keep smiling because the headache disappeared when I woke up. Health really is everything.
This morning, in between the blood draw processions, I played pool with Brad. He will be using the money from this study to buy a new used car. His vehicle recently died.
I ask him if he’ll do another study in the future. He does not even hesitate: yes. Of course, he’ll keep an eye out for studies that are quick, easy and convenient.
I’ve had plenty of time to speak with Mario. Apparently, he also considered the infamous sperm count study, but could not bring himself to participate at his place of work. According to him, some of the sperm study participants have taken as little as two minutes to produce a sample. Conversely, one was in the “Velvet Room” for 90 minutes and came up dry. Stage fright, apparently.
I thought the horror stories of missing the cup or not having enough sperm were bad; he tells me one guy said his mother called him on his cell phone when he was in the room. That killed his mood for over a half hour.
Interestingly enough, some people in that study bring their own porn with them. Other participants end up stealing the porn provided in the room. I have actually seen the room and it frightened me. There is a chair with a long roll of paper covering it (like at a dental or doctor’s office) where you can rip off the old layer and pull down a new one. That isn’t even the craziest thing (apart from the porn itself, of course).
The craziest thing is that there is a small fold-up chair placed to the left of the comfortable one. That one is for the participant’s spouse or significant other. They can provide moral support (and even take their clothes off), but they cannot directly lend a hand, so to speak. That entire room belongs in the Twilight Zone.
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Also in the facility this weekend is “Sandy,” who is taking part in an epilepsy study. This site is testing a new drug, but it is difficult to find patients for this study. They need people who have epilepsy, but do not take any medications.
This is Sandy’s first study. Ironically, she used to work for a large pharmaceutical company. Her job was to take calls and help direct people to treatments and programs that would be helpful for them. Now, she may be helping add another treatment to the options.
Her main motivation, apart from hoping that her efforts will eventually help her and others with epilepsy, is to get enough money to go visit her grandchildren. She has ten blood draws today, and is not a big fan of needles. She looks a bit like a pin cushion as they’ve had to take from both arms and hands as her blood has not been free-flowing thus far. I can tell she’s in a lot of pain, and she admits she’s considered leaving more than once. Then, she thinks of her grandkids and decides to “brave it out.”
Despite it all, she says she still plans to do more studies in the future.
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It’s amazing how quickly a person’s demeanor can change. Brad had been cruising through the day just fine, then, at about 11 a.m., he looked quite pale after a blood draw. He felt weak and sick, as well. Since safety is the main goal, he was immediately taken to a private office in the Conduct Room where they checked his vitals. His blood pressure was a bit low.
After resting a while, he felt a lot better. He confided in me that he thinks it’s from not eating since 9 p.m. or so last night. We won’t get to have lunch for about another half hour, so that’s almost 14 hours of fasting.
There is a strong sense of community here, as everybody knew immediately what had happened and keep asking him how he feels as the day progresses — just as they did during my migraine debacle.
Meanwhile, unrelated yet at almost the same time, Roger had a similar experience, but more intense. He and Minny were on their way to the mall (they can come and go from the facility since he is not in an overnight study), and two blocks away he became “violently” ill and turned white.
According to Minny, he hasn’t vomited once during his entire bout with cancer (which has been for over four years), including during his chemotherapy treatment. He can’t say that anymore.
He was brought back here immediately and taken into a private room in the Conduct Room so they could take vitals, observe him and hook him up to an IV.
The odd thing is, this morning — as I taught him how to play Pyramid Solitaire — he said he was doing well. He was feeling quite optimistic, in fact.
Fortunately, he began feeling better again shortly after being back at the facility. It’s impossible to determine the root of his episode at this point. It could be the medication, of course, but it could be the cancer or the fact that he had a light breakfast (which he thinks might have something to do with it).
Regardless, it’s a good reminder that there is always an element of anxiety present for everybody involved in a medical study.
As the long day crawls by, my eyes get heavier and heavier. It’s barely after 6 p.m. and I could fall asleep right now. I’m also cold. These things are significant because I’ve noticed every Saturday and Sunday a small portion of our group has always been sleepy and cold. It seems to be random, too. Are they symptoms or side effects, or are we just bored in a facility where they keep the thermostat at 71 degrees?
Final Freaking Sunday of Study
It’s 9 a.m. and we’ve already had our first of two blood draws today. It will be an easy day, with very little to do (yet still somehow mentally exhausting), and I realize than in 24 hours I’ll be finished with the study. I will be very relieved at that time. It’s been a weird 17 days and I’m looking forward to my life (such as it is) no longer being on hold.
It takes a lot of patience, discipline and willpower to be in a study, especially if it requires overnight stays. For so-called healthy individuals, nothing makes you feel sicker than being stuck in a medical facility with multiple health tests and procedures being performed on you.
Still, the last 17 days have provided me with a fascinating insight into the wild and wacky world of medical research. Seeing what this site’s staff has gone through during the weekends has earned my respect. I can appreciate all the long hours, deadlines and the pressure. It’s extremely hard work.
I have retained a strong sense of skepticism on medical research, but have loosened my grip somewhat. Even when the intention is solely motivated by noble reasons, there are so many factors that can affect the findings in a study and their overall veracity.
While I believe the research staff here is honest and ethical, that might not be the case in other facilities. And, even if everybody who works on a staff is honest, they are also human. Inevitably, blood draws are not always taken at the appropriate designated time. A vein goes dry or something unexpected happens, and the precise timing falls apart. Does that really affect the study much? Perhaps not, but so many other little things can be forgotten or overlooked. There is an unbearable amount of pressure on researchers to dot every “i” and cross every “t.” Sooner or later, that pressure will cause mistakes.
Then there are the patients, who are also human and more than capable of dishonesty and unethical behavior. Just five minutes ago I witnessed one diabetic slyly slip a plastic coffee cup full of strawberries to a fellow study mate, who hid it between her waist and her chair. It could not have been coincidence that a nearby medical research employee’s back was turned to them at the time.
The diabetic participants had strawberries as part of their designated breakfast, so I know they are allowed to eat them. However, each patient has a strict diet of certain foods distributed in exact amounts. What harm could a few extra strawberries cause? I don’t know, but I imagine the protocols are in place for a reason.
Of course, what is the alternative? You can’t control every facet of a study, and if you tried to be too strict, who in their right mind would subject themselves to such scientific scrutiny?
In a perfect world, there would be no problems or adverse events to deal with, but that simply can never happen. People do not live in a vacuum.
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With the minutes crawling by, I can’t help but think of my paternal grandmother, a strict, tough old bird who I often feared. It was not so much because she was mean (although she was); she just seemed to look death in the face daily and slap it silly.
For as long as I can remember (and before I was born) she survived on borrowed time. She was a guinea pig herself, albeit in a much more extreme capacity. After a bout with Valley Fever, one of her heart valves becamed damaged. So, in 1952, she agreed to become one of the original patients of an experimental new valve replacement procedure. Several of the country’s top cardiac doctors were present. It was broadcast on a closed circuit TV show where a hall full of doctors and surgeons witnessed the operation. Historically, it was a huge deal.
My father recalled that none of the other test patients survived more than 13 years after the surgery (about the length of time the doctors expected the replacement valves to last). My grandmother somehow lived for four more decades. She later had problems with a second heart valve in 1983 and had a St. Jude valve replacement at that time. It was supposed to last eight years. She lived for over a dozen.
The woman was a medical marvel herself, and I can’t imagine how long she might have lived if she could benefit from the medical advances of today.
I do not bring her up to dwell on missed opportunities. Instead, I will emphasize the promise. I realize that there is a chance that the heart disease drug I tested may someday go through the other phases and be on the market. It could take a while, but if it gets there, it might mean an extra decade of life for a lot of people who, right now, don’t even have symptoms of heart disease yet (maybe even me!).
That’s pretty amazing when you think about it.
Postscript (Final Monday of Study)
It’s Monday morning and I’m free at last. We spent the morning engaged in our final blood draw, as well as an ECG, vitals, urine sample, and doctor exam. Everybody was happy to sign out, get the check, and go back to their lives.
Jordan informed me that he’ll be calling in 30 days to check up. He will do the same with Vida. We were the only two with adverse events. They’ll probably ask me about headaches; as for Vida, she had mentioned two minor heart flutters that quickly passed. Despite that occurrence, she’s already looking for the next study. She’ll probably have to allow 30 days to elapse before she can sign up for another one.
She asks me if I’ll ever consider doing another one. I have been thinking about that for quite a long time now. The prospects of staying in a medical facility for another weekend seems insane. I guess it depends on the parameters of the study. If I do it again, which I suspect I will, I will be more prepared going into it. I will ask more questions next time, as should anyone else who is considering taking the medical research plunge.
If you want to find out about which clinical trials that you might qualify for, ask your physician or visit www.centerwatch.com. Visitors can use the site to sift through detailed information on more than 41,000 active industry and government-sponsored clinical trials.
If one interests you, my advice is to learn as much as you can about the place hosting the trial, the pharmaceutical company conducting it and the study treatment itself. If you make it to the orientation process, pay close attention and ask any questions that come to mind. Make sure you know what treatments will be used and how, and how long the trial will last. Ask what the main purpose of the trial is, as well as how many participants will be involved and what the risks will be. All of them.
Verify that you will not have to pay for any part of the trial; conversely, make sure you know precisely how much you will be compensated. Find out what will happen if you get harmed during the trial. If you are a special needs patient opting to take part in the study for medical benefit reasons, see if it will be possible for you to remain on the treatment after the trial (provided it has had a positive effect on you). While all of this information should be in the consent form, it’s smart to verbally confirm them with the consenter to help you better understand all the details.
Prior to that, you should consult your physician, even if you are a healthy study candidate. Not only will your doctor have more access to insight on the study and the host site, but he or she is more likely to be knowledgeable on the treatment itself and its potential problems and side effects.
If your doctor approves, you should still remain cautious. If you have any doubts whatsoever — about the host site, the treatment, or anything else — do not participate. There is no financial compensation adequate enough to lure you to take any significant risks. However, if the pay-out money seems really high, then there is probably something that does not add up.
If you are satisfied with everything and sign on the dotted line, be fully aware of the fact that you can nullify the contract at any point. You can stop the study whenever you feel uncomfortable. Also, keep in mind that most clinical trials are structured in a way where you will get paid for the steps you complete.
If you make it all the way, you might experience a feeling akin to the successful completion of boot camp training. Of course, being in a study is a much less harrowing ordeal.
Still, those who finish a clinical trial can take satisfaction in the fact that they have contributed something positive to the world. It does not matter if your study leads to a miraculous cure or a dead-end street. Both successes and failures are required in order to move forward in a trial-and-error system.
Ultimately, participation is the key to success. If nobody is willing to place trust in the medical research industry and take part in clinical trials, then there can be no forward progress. Then there truly would be no hope, and that’s not the kind of world anybody wants to live in.
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