I Was a Medical Experiment! (Part Four)

For those curious about all the details that go on during clinical trials, I decided to be a "guinea pig" in the name of medical science for one back in 2008. My wife worked at a medical research center at the time and I had no idea what occurred during the drug approval process. Needless to say, I was curious.

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.

*************************************

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.

*************************************

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.

*************************************

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.

*************************************

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.

*************************************

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.

I Was a Medical Experiment! (Part Three)

For those curious about all the details that go on during clinical trials, I decided to be a "guinea pig" in the name of medical science for one back in 2008. My wife worked at a medical research center at the time and I had no idea what occurred during the drug approval process. Needless to say, I was curious.

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.

*************************************

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...

I Was a Medical Experiment! (Part Two)

For those curious about all the details that go on during clinical trials, I decided to be a "guinea pig" in the name of medical science for one back in 2008. My wife worked at a medical research center at the time and I had no idea what occurred during the drug approval process. Needless to say, I was curious.

After three long weekends (and 17 days) I learned a lot. Perhaps a little too much. This is what happened. Part One already covered the screening and orientation process. Now, Part Two focuses on the first weekend of the clinical trial. Two more parts will follow. All information and research was current in 2008 when this was originally written.

First Friday of Study
I was approved, much to my chagrin. Though the study has not officially begun, I’ve already made my first sacrifice. I will miss a concert with my wife tonight. It’s not a big deal, but it reminds me that even people seemingly without lives have plans on just about every weekend.

Anyway, my bags are all packed and I’m ready. At least I think I am. I’ve been prepped quite a bit on what to expect, but I am still anxious. I don’t really know what I’m in for, which reaffirms my decision to document everything because I sure wish I had somebody else’s experience to draw on right now.

*************************************

It’s 7:30 p.m. and the nine participants have been checked in one at a time. There are the usual medical tests — urine sample, blood pressure, pulse — but this time there was a new one. Breathalyzer. Apparently, you blow into a plastic tube for 15 straight seconds and they can read your blood-alcohol level. I feel like I’ll pass out from dizziness. Oh, the irony.

By now, I’ve seen (but not met) all of my co-participants. Steve is not here, which means either: 1) he did not qualify; 2) he will participate in the second or third group of the study in a few weeks; or 3) he was chosen as an alternate, who is on standby status in case an active participant opts to leave or is asked to leave, for whatever reason.

It’s quite a mix of people in terms of race, creed, age and even language. The majority of participants speak Spanish. At least three or four people here already seem to know each other. Perhaps they have participated in other studies together, or know each other in the outside world. Either way, having a friend alongside must make it easier.

The site’s employees checked me for contraband. I learned from “Jordan,” the manager of the study who took my blood pressure and other information, that the reason they don’t allow mouthwash (and other toiletries) is that many contain alcohol in them. Apparently, there are some people who ingest such products in a desperate attempt to get a buzz.

It should be a relatively uneventful night, which will give me time to study our six-page schedule for the next three weekends. It shows when we’ll have meals, snacks, etc., and when we’ll have water restrictions. It also indicates when we will be administered the drug, when we go to bed and wake up, when our vital signs will be checked, blood drawn, etc. These people are nothing if not organized.

First Saturday of Study

I awoke at 6 a.m., my aching back serving as my own personal alarm clock. I can’t say the bunk beds are terribly comfortable, but it could be worse. In fact, I have slept on much worse in many so-called “Four-Star” hotels. Besides, I should count my blessings since I have no roommate. Another set of initials are listed on the door but he never showed, or, possibly, he violated the protocols somehow and was booted.

It isn’t long before I have my vitals checked. In the next 12 hours, my blood will be drawn ten times. After the first draw, I swallow four white pills. Then I learn that some of us will skip breakfast on Saturdays as part of the study. Thus, I’m fasting until lunch. I will not eat for a span of about 15 hours.

The process of recording the information for the study is interesting. Jordan moves from person to person taking temperatures, blood pressures and blood samples in precise intervals. Huge digital clocks (in military time) adorn the walls on each end of the Conduct Room so he can call out the time to an assistant who is recording the information in huge white binders.

By now, I’ve had a chance to absorb some nuances and details pertaining to medical researchers. For starters, they are funny. In the testing room loom three refrigerators of incremental sizes used to store “samples.” The appliances each have an individual name tag. It takes a delightfully strange person to name a refrigerator “Jim” or “Bob.”

I’ve also discovered that this place is conducting a cancer study, which is not so unusual, as well as an adolescent smoking cessation study, which I hope is. They are enrolling kids between the ages of 12 and 16. I don’t know how much they have to smoke daily, or for how long. What I do know is that it must be Hell filling up such a study. I’ve seen three participants in the building and all I can think is: How did they tell their parents? After all, minors need parental consent to partake in a clinical trial. Compounding matters, these kids may earn money by participating, but the check will be written to their parents. They don’t have to see a cent.

The important thing, though, is that they quit, right? Maybe the kids aren’t financially motivated to participate; they just want to avoid lung cancer down the road. Jordan tells me that the study utilizes a pill that will stimulate the effects of smoking, which will ultimately help the kids wean off cigarettes. The treatment has already worked with adults, but the drug company wants to adjust the dosage properly so it will work on teens, as well.

The wonder drug may not work on them at all or even if it does, it will not be administered to everyone. Some will take placebos. Jordan laughs when he tells me that he’s seen placebos work just as effectively as the real deal. “Power of the human mind,” he says as he shrugs.

Jordan strikes me as a decent guy. He did not think much of the medical research study field before he started working in it, but his opinion has slowly shifted back to the other side of the pendulum.

One problem Jordan has is that some pharmaceutical and research companies are more motivated by making dollars than finding cures.

However, Jordan added, most people working in the actual research process do it because they want to help people. People don’t sign up to study urine samples or examine people with horrible diseases that inflict intolerable pain just to make a buck. Well, most don’t anyway.

Jordan is happy at this particular medical research company. It is a rookie startup, full of hope and energy. It’s kind of inspiring to see the people working hard and putting their hearts into it. Many have endured long weeks only to be rewarded with weekend shifts. Most are salaried, so you know they are not killing themselves for overtime or extra pay.

Watching their efforts, my own view of the medical research industry has improved somewhat. Of course, most of the public already has passed damning judgment over research facilities of late. Why? Part of it may be due to the bad news vs. good news factor. Why is a vast majority of TV news programming about murders, rape, the death of children, natural disasters, wars, etc.? It grabs people’s attention, and that’s what they remember. People never forget a tragedy.

Unfortunately, when you look back at the history of the medical research industry, there have been so many tragedies.

I don’t know how many people are familiar with the “Tuskegee Syphilis Study” conducted between 1932 and 1972. However many, it is not enough.

The full name of the research study was the “Tuskegee Study of Untreated Syphilis in the Negro Male.” Its participants included 399 poor black males, most of whom were illiterate sharecroppers in Alabama. They all suffered from syphilis; however, they were never provided with any genuine treatment. For that matter, they were not even informed of the diagnosis.

The researchers told the men they simply had “bad blood” and that, if they volunteered, they would be given free medical treatment, meals and burial insurance in case they died. The researchers, who were clearly rampant racists, collected most of their data during autopsies. They weren’t concerned about curing the participants at all. They wanted to see how the disease spread and killed.

When the study first began, treatment for syphilis was usually more harmful than effective, but that changed years later when penicillin was accepted as an effective way to combat the ailment in 1947. Despite this medical breakthrough, the participants received no penicillin, only the prospect of death. It was often a slow process, too. Before dying, syphilis sufferers could be plagued by tumors, heart disease, paralysis, blindness and insanity.

The nefarious study continued for 40 years until the early 1970s. At that time, an expose story of the inhumane research broke in The Washington Star. The study was considered the longest non-therapeutic experiment on humans in medical history. In all, 28 of the men died directly from syphilis and another 100 died as a result of complications from the disease. Additionally, 40 of the men’s wives were infected with syphilis, and another 19 of their children were born with congenital syphilis.

That one shocking example is probably enough for some to never trust the veracity of medical studies or those who conduct them. Too bad there are so many other prime examples. Another horrifying case that made more mainstream headlines involved the Nazi medical experiments on Jews during World War II. That time, however, the subjects weren’t coerced into volunteering. They didn’t have a choice.

One set of research tests involved placing naked Jewish and Russian prisoners in icy vats where they learned that most prisoners lost consciousness or died when their body temperature dropped to 25 degrees Celsius. Others were placed under sun lamps hot enough to burn skin.

The appalling list goes on and on. Other so-called experiments revolved around: genetics, interrogation and torture, infectious diseases, sterilization, traumatic injuries, and surgery without anesthesia.

While those are extreme, isolated examples, people will never forget them, just like they’ll never forget about Thalidomide, a drug that was widely accepted throughout the world over 50 years ago. It was mostly prescribed to pregnant women in the late 1950s and early 1960s to combat morning sickness and help them sleep. However, there was an unanticipated side effect.

From 1956 to 1962, the drug caused about 10,000 children to be born with severe birth defects. Many were born without limbs; others suffered from phocomelia, a flipper-like appearance of the hands and feet to due improper bone formations.

In response to the unforeseen Thalidomide complications, Congress passed a law in 1962 requiring drugs to be tested for safety during pregnancy before they could ever be approved for sale in the United States.

While the story is a dark passage from medical research history, Thalidomide is a classic example signifying the importance of the Food and Drug Administration. While the drug was being prescribed to women all over the world by 1960, it was not approved for sale in America yet. A company in Cincinnati, OH, sought to change that when they applied for approval in September of that year.

The application was given to a rookie reviewer at the agency, Frances Oldham Kelsey, who had joined the FDA only a month before. In the 1940s, she had conducted an experiment on rabbits for quinine, a synthetic treatment for malaria. The study revealed that pregnant rabbits were unable to metabolize the drug as quickly as adult rabbits, and embryonic rabbits could not metabolize it at all. With that experience in her background, she was concerned that Thalidomide could pose the same problem with pregnant women.

She was right. A drug perfectly suitable for non-pregnant adult patients turned out to be a serious hazard to children, pregnant women and their unborn babies.

Ultimately, Kelsey rejected the application for Thalidomide. In fact, she turned down the drug another five times as the company continued to submit a new request every 60 days as the law allowed. She never budged on her ruling.

These days, the public continues to foster a distrust for drugs on the market. Rofecoxib is the most dramatic recent example. It is better known under its Merck marketing name: Vioxx. It was approved by the FDA in May of 1999 (after undergoing years of research) as a safe and effective drug to treat osteoarthritis, acute pain conditions and dysmenorrhoea (cramps or painful menstruation).

Since then, over 80 million people worldwide have taken it. Suddenly, Merck pulled the rug out and voluntarily withdrew the drug from public consumption in September of 2004. The pharmaceutical company had developed concerns about long dosages leading to an increased risk of strokes and heart attacks. By that time, Merck had made over $2.5 billion in Vioxx sales in the U.S.

What was once a windfall now turned into a potential financial free fall. Within days of recalling Vioxx, Merck’s stock fell more than 37 percent. Since that time, there have been over 10,000 lawsuits filed against Merck, and approximately another 200 class actions by those who have suffered from adverse cardiovascular events ascribed to the usage of the drug.

So far, some juries have sided with the plaintiffs on lawsuits against the company; a few have even issued multiple multi-million dollar judgments. In 2005, in one of the most famous Vioxx cases, Carol Ernst was awarded over $250 million in damages for the death of her husband, Robert, despite the fact that he had a history of heart disease.

The settlement was later reduced substantially due to a Texas law that caps punitive damages, but it is still unclear how much, if any, will be paid out. Merck could eventually appeal the verdict successfully.

Just three months after that, Merck successfully defended itself in a separate case. No matter what happens here on out, Vioxx was a huge public relations disaster for the entire medical research industry. It remains to be seen how much Merck will have to pay in the courtroom, as well as the court of public opinion.

People remember tragedies, but what about the good? Merck, founded in 1891, has been a leader in global research for decades. It’s hard to find a household that does not contain at least one Merck drug in its medicine cabinet. Admittedly, I have Maxalt in mine, which is a wonderful drug that effectively ends migraine headaches. I am quite grateful to them for that.

Incidentally, the pharmaceutical giant does not always charge for the drugs either; they have donated untold millions in free medical treatments over the years. One recent example is the company’s donation of $80 million, or 200 million pills, to help fight a parasitic worm disease affecting millions in Africa, most of which are children.

The company also will inoculate one million women in undeveloped countries by donating doses of its cervical cancer vaccine, Gardasil. Those are just two examples; there are many more. Will any of it contribute to the public trusting Merck again?

Personally, I came into this study with enough grains of salt to fill up a plastic sample cup. There remains a large part of me that wants to cling to the belief that there is much good to be done at a medical research facility, regardless of who is sponsoring the study or what the treatment is for. At the same time, another part of me believes that if you shine enough light on anything good in this world, it will inevitably produce a shadow.

First Sunday of Study

Today should be a cakewalk. On the schedule, there are only two listed blood draws — one in the morning and one late in the evening. That’s a far cry from yesterday.

Among our participants is a young man who is studying to be a nurse. He has a crucial test on Monday morning. He will literally leave this site and go take it. Still, “Ron” (RN -- get it?) could not be happier with the timing of the study. Normally, he says he’d be out roller skating until late Friday and Saturday nights and possibly attending a barbecue on Sunday. His studying time would undoubtedly be infringed upon by enticing options of leisure.

Now, he has tons of time to kill and nothing else to do. He has studied for hours and is quite confident that he will perform better on the Monday test than any he has taken so far.

I also spoke with “Vida,” the only woman in our group. I asked her if it feels strange to be in a study with a bunch of men. “Everyone has been a gentleman so far,” she smiles.

Vida is no stranger to the medical research world. Since 1998, she has participated in numerous trials, usually about a handful a year. While her husband works full-time, she supplements their income.

So far, she has avoided any serious side effects. She does not seem the least bit concerned, but she did mention one that gave her pause: “bleeding in the brain,” she says with raised eyebrows. I laugh and wholeheartedly agree.

The worst problem she has ever endured while taking a clinical study drug was vomiting. It was a listed side effect, and, naturally, it wasn’t the most pleasant experience. It did not deter her from continuing to participate in other studies, however. She participates at many different medical research sites, as well. Her longest “stay-over” was 18 days straight.

Next, I strike up a conversation with a couple, “Roger” and “Minny.” She is here to offer support for her husband, who is taking part in an oncology study. He was diagnosed almost five years ago with prostate cancer. It has since spread to his hip region.

According to Minny, her husband could easily walk faster and further than any of the young guys in the facility... before the chemotherapy anyway. Now he has no energy and moves at an infinitesimal pace.

Roger may feel weak most of the time, but he still smiles a lot. He enjoys ”talking with somebody other than a doctor” for a change.

Minny says they have been allowed to stay at the facility despite it not being an overnight trial. They live very far away, so it would be inconvenient to travel back and forth often. According to them (and to Vida, as well), this is the nicest “small” facility they’ve been to and the facility’s employees are all extremely kind and helpful.

The last study Roger subjected himself to was for a cancer-fighting pill. It didn’t work on him. Now, he’s trying a “liquid medication” study. I am surprised to learn that though Roger’s test drug is only in Phase I, he has already researched and read some promising things about it online. It has met with some success in killing lymphoma already. According to Roger, one woman in the same study for the drug has seen improvement in a large tumor behind her ear. It has shrunk by about 50%.

He will take the medication on a 21-day cycle. He’ll be on it for 14 days, then off for the final week. They will take another MRI so they can track the progress of a particular tumor. He will continue the treatment if it has shrunk at all, or at least, halted in its tracks. If that is not the case, then Roger and Minny may move on to the next trial.

Another participant, the youngest one in the group, knows somebody who knows somebody who works here. “Brad” is constantly playing pool and video games, watching TV, texting on his phone, and asking people at random: “Do you feel any side effects yet?” So far, the consensus has been “none.” That doesn’t seem to comfort him.

If he starts becoming dizzy, he may have a heart attack. He’s quite nervous, unaware that his youth (he is 19) would probably protect him more than the rest of us. That sounds a bit dramatic. I really don’t think there’s any danger. If Vida could do this for a decade without any problems, then why should it be any different for us?

*************************************

Giving blood the first time today was a pain. My stingy right arm absolutely refused to give any up. Undaunted, Jordan faked right, and went to the left arm. Even with a butterfly, he could only draw a small amount. It’s a good thing I’m last in the chain or I’d be holding the process up. Every two minutes the blood must be drawn. If I was first, they would have had to stop trying and move on since everything is done on a precise time frame.

Since I’m last, Jordan tries a third time. The butterfly works on my right arm, finally.

We were served breakfast today: fruit salad and a huge burrito stuffed with eggs, cheese and bacon. For dinner, it’s fried chicken, potato salad, macaroni salad, rolls and butter.

All the major meals we have been served thus far have been catered, which surprises me. I was expecting cafeteria-quality food. Instead, it’s been take-out all the way. This is a new company, so perhaps it hasn’t had time to set up a kitchen staff or find somebody to prepare all their meals for them.

First Monday of Study

After our only blood draw of the day, we eat a breakfast of giant-sized muffins and croissants. Staff members cut off the plastic ID tags wrapped around our wrists. Everybody flashes a big smile in response, as if they just passed a parole hearing.

I spent the morning learning more about the teen smoking study, which I find interesting because it’s so different from all the others. Apparently, there are a lot more than three participants (the only ones I’ve seen) in the study at this facility. The funny thing is, there’d be a lot more if there hadn’t been so many screen fails.

A screen fail is when the research staff discovers a fact about the patient that excludes them from the participation parameters of a clinical study. For my study, a 56-year-old person would be disqualified as the age window is between 18 and 55.

Other restrictions might be that a person is on a medication that is considered unacceptable, or a person could catch the flu at the last minute and be told to come back and screen again when well.

Apparently, the vast majority of screen fails are due to intoxicants. People who swore they never touched a drop of alcohol or drugs in their lives often get sent home when they do not pass the urine and breathalyzer tests — even teen smokers, apparently. Numerous 12 to 16-year-old kids failed because they tested positive for marijuana. One candidate even failed due to cocaine use. The puzzling aspect of it all is that they are told ahead of time that they will be drug screened.

Continued in Part 3...

I Was a Medical Experiment! (Part One)

Curious about all the details that go on during clinical trials, I decided to be a "guinea pig" in the name of medical science back in 2008. My wife worked at a medical research center at the time and I had no idea what occurred during the drug approval process. Needless to say, I wanted to learn more.

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.

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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. 

Visions of Steve Carell in The 40-Year-Old Virgin screaming incomprehensible obscenities roll around in my head. When the employee rips the various little circles from my legs, chest and stomach, I don’t feel a thing.

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...