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.
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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.
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?
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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...
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