Anatomy of a Drug Trial

July 23, 2010

23 July – Exactly five years ago, in exchange for the most miserable month of my life, I got paid $4,800 to test the effects of a drug made by GlaxoSmithKline. 

Ana Cantú
American Statesman

You know where you’ve heard the name GlaxoSmithKline recently, right? That’s the company on the verge of losing the approval of the Food and Drug Administration for the diabetes medication Avandia after regulators discovered omissions in a key clinical trial report. On Wednesday, the FDA ordered Glaxo to stop enrolling people in another Avandia trial. 

According to a review reassessing the drug’s safety by the FDA’s Dr. Thomas Marciniak, a number of patients taking Avandia appeared to have serious heart problems that were not counted in the study’s tally of adverse events, otherwise known as side effects. 

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” he wrote. 

It can cost hundreds of millions of dollars — in some cases, close to a billion — in research and development for a drug company to secure FDA approval. 

By the time a drug gets to point where it can be tested in humans, the pressure for positive results in clinical trials is immense. And I found that out first-hand when as one of the healthy volunteers — a human guinea pig — in a study that tested the effects of Norvir, an HIV drug made by Abbott Laboratories, when coupled with the antidepressant Wellbutrin, made by GlaxoSmithKline. 

In exchange for that $4,800 paycheck, I spent about a month going in and out of a blocky silver building in an office park not far from Austin-Bergstrom International Airport, the site of a contract research lab that conducts medical studies. 

During the lab’s second clinical trial of the Norvir-Wellbutrin combination, which I chronicled in a personal blog, I was known only subject No. 40.

July 12:  I check in tomorrow for 4 days. I’ll be taking an antidepressant and an AIDS drug in combination for about a month.

July 13:  The facility is freezing. We’re still waiting on blankets. I should’ve brought a hat and gloves. You can tell the people who do studies regularly by their baggage — they bring extra pillows and blankets and huge rolling suitcases. The building is pretty new and it’s painted in all kinds of “modern” colors like bile, which complement the black-and-white tiled floors nicely.  Subjects sleep 8 to a room in bunk beds, though there are only 3 people in my room…  My first dose of Wellbutrin is tomorrow. I hear it gives you crazy dreams.

July 14: I’ve been stuck so many times today I feel like a junkie. I had to be up by 6:12 a.m. to check vital signs and get a pre-dose blood draw. Then I had breakfast, which I had to finish: two potato, egg and cheese tacos with pico de gallo and a carton of 2% milk, which I don’t like. I took the Wellbutrin at 7:27, so precisely every hour after that I’ve been having blood drawn. For the rest of the day, it’s blood draws only every 2 hours. I carry around a clipboard that has all my procedures and meals scheduled — everything has to be done exactly as it says on the sheet or they can dock pay off your study-completion bonus.  Amusing sign near the toilets: Please do NOT use cellphones in urine monitoring stations.

July 15:  Dinner was decent — teriyaki chicken, rice, salad with Italian dressing, a hunk of zucchini bread and a sugar cookie. I tried the cookie and didn’t like the aftertaste so I hid it in a spare napkin and arranged everything else on the tray to conceal it.  The cafeteria workers check how much of our food we eat — we’re supposed to finish at least 50% of everything. Sometimes it’s hard, like with yesterday’s trail mix. I hope we get a good snack, which I will take my first bite of at precisely 9:32 p.m.  About half of the subjects have done trials before and say that ours isn’t so bad, even with all the blood draws. Apparently, there are some where you have them every 15 minutes…  The people who usually play Monopoly switched to Uno.

July 18:  Yesterday I had my first bad blood draw.

July 20:  Tomorrow I start my doses of Norvir, the AIDS drug. Fun, fun.

July 23: I started on the AIDS drug on Thursday — 300 mg twice a day. The dosage gets upped to 400 mg tomorrow. I don’t feel bad yet, though I’m sleeping less than normal. And today my stomach objected to the egg facsimile we had to eat.

July 25: I was pretty excited that I didn’t get sick after my dosings…  I think the secret is to not drink the milk.  And not to eat more than 50% of the food.  I’m becoming an expert in artfully rearranging things on my plate so it looks like I’ve eaten. They (try to) make us eat after taking the giant AIDS pills, but since we get the same few meals over and over, it’s gotten really hard to do.  Plus, there’s a chance you’ll get sick after so you really don’t want to see nasty food twice, if you get my meaning.

July 28: I discovered that I feel better if I don’t eat after taking the horse pills. This morning, I refused to eat the breakfast tacos and felt fine. So I followed the same strategy at dinner — I did eat the peas and carrots and drank some caffeine-free root beer, but most of the meal was untouched.

Over the course of the trial, as a result of a near-constant state of nausea, I lost about 10 percent of my body weight.

To keep up my strength, for lunch, I’d go to a fast-food restaurant and order the heaviest combo on the menu (double bacon cheeseburger, fries and a huge non-caffeinated beverage) and eat as much as I could before I started to feel sick again.

Every night, insomnia cut my sleep to three hours.

Aug. 1:  The study started out with 20 subjects, but 6 were eliminated during the in-patient stay by the drug company sponsoring the trial for various reasons (including drinking caffeine within 24 hours of check-in).  For about a week, there were 14 subjects. Then they started dropping.  The first one to go was a girl with a pronounced Texas twang named Denise, who had severe jaw and tooth pain. Then extreme nausea and emesis (the clinical term for vomiting, I discovered) claimed April. Jo Kay, Paula, Amy, Alyssa and Carrie went one after another.  Now we’re down to 7.  In what I view as biological injustice, none of the males have shown noticeable symptoms.

Aug. 2: I had to go see an opthamologist today, just for my safety, since I reported a migraine with aura a few days ago. Unfortunately, I’m fine. Curses. I was hoping I could get medically excused from the study — that way I’d still get paid. But it looks like I’m going to have to finish it. Only 10 more days of dosing to go. My current side effects include oral numbness and tingling in my extremities.

Aug. 6: It’s another day in lockup: cloudy skies (I think) and cold air conditioning. The day got off to a bumpy start when I started to black out while reporting my side effects. Darkness closed in from my peripheral vision and then I saw nothing but big colored spots.

That morning, we were standing around in the cafeteria waiting to dose. All of a sudden, I couldn’t see and lost the ability to balance. If I hadn’t been standing between two of my fellow subjects, who grabbed me and held me up, I would’ve slammed into the floor. I knew I hadn’t fainted; I could still hear just fine, but all I heard was chaos as everyone around me freaked out. I dropped into the nearest chair and put my head between my legs while the study coordinator called the on-site paramedics. While the coordinator frantically called the staff doctor, a paramedic checked and re-checked me. I did fine as long as I wasn’t on my feet for too long. The doctor cleared me to keep dosing.

A few days after my first blackout episode, during a scheduled outpatient visit, one of the study coordinators said I had to be examined by the on-staff doctor. “Why?” “The sponsor is concerned about your side effects,” she said.

The drug company had a dilemma. To submit trial results to the FDA, the study couldn’t fall below seven participants. But, unfortunately, one showed signs of serious side effects and if those results were submitted, approval was highly unlikely. If my results were dropped, the FDA would never know about the problem and the drug company could start fresh with a third trial. However, the first clinical trial had to be scrapped because too many subjects dropped out as a result of their side effects, and it looked like the second study could soon follow the same path. To gather enough healthy volunteers who fit the protocol for a third trial would require a lot of time and money, and it wasn’t something the sponsor was willing to do. So, in the end, my results and I stayed in the study.

Aug. 21: So yesterday I had the exit screening/physical for my drug study. I had to have my blood pressure checked 3 times because it was low, even for me. The paramedic checked me, but I was asymptomatic. She asked how I was feeling. “Fine, especially now that I’m off the drugs.” She said, “Well, it was for the good of mankind.”

“I guess … and the money.”

Because the trial ended with the magic number of seven volunteers, the results could be submitted for review and the FDA had the opportunity to see the data. But what happens in the trials in which drug companies drop some of the subjects with the worst side effects?

Actually, we’ve seen what happens — with Avandia.

HIV Drugs like Norvir cause anemia, blood coagulation problems, bone marrow suppression, cancer, diabetes, heart problems and other diseases.  For the complete list of HIV drugs that compromise immune function and kill, visit OMSJ’s Drug/Disease Matrix.

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