Human Subject: An Investigational Memoir

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11. Elevated

“L'esprit a naturellement des tendances systématiques, et c'est pour cela que l'on cherche à s'accorder plutôt sur les mots que sur les choses.”

The day described in chapter 9—day 14 of the drug study—had been a Thursday. The next evening I discovered that, in the course of a project I was working on, I had made a mistake that caused extra work for someone else. That wasn’t too unusual, as I’m not always the most careful worker (during a brief career as an inspector of printed circuit boards, one of my co-inspectors started re-inspecting every board that I had designated as done). But for the first time in weeks I wasn’t overwhelmed by self-recrimination and guilt. I was able to go on with my life after just an “oops, sorry.”

Hmm, I thought. Could I be feeling the effects of a drug? Could what Dr. K had told me about guilt be true? Or was this just a placebo effect provoked by what she’d told me?

When the next day dawned anxiety- and depression-free, I was positive that the change wasn’t placebo-induced. Why was I so sure? Because by any objective criteria, my life was a mess:

If a pathetic loser like me could feel hopeful and guilt-free, the feeling had to be chemically induced.

Four days later, I returned for Visit 5 (Day 20) of the depression study. Riding up in the elevator, I noticed for the first time a button set apart from the others in the button panel. It looked something like this:

Earthquake button

I pointed it out to the one other passenger, a woman in a blue-flowered dress, and wondered aloud whether we were supposed to push the button in the event of an earthquake or in order to cause one. “I don’t know,” she said. “I’ll have to ask my friend who works with elevators.” We both got off at PsychoPharm; I don’t know if she was an employee or a study subject, because she headed toward the office while I headed toward the restroom, and I never saw her again.

I told Nurse L about the big change in my mood. After asking the battery of questions about emotions, sleep, appetite, and energy, she told me that my score had gone up 50 percent, but that “we aren’t out of the woods yet.” She didn’t really explain, but I presumed that because my energy level had only gone up a bit, and I still wasn’t sleeping all that well, we couldn’t say that my depression was cured. What she didn’t realize was that even when I feel good, I lack energy.

At that visit Nurse D again expressed concern about my low blood pressure. While lying down, I was able to think stressful enough thoughts to raise it to 90 over 60. But after I stood up, it fell to about 80 over 50. So I finally got to meet the principal investigator, Dr. S, when he came in to talk to me about this disturbing (but not clinically significant, he assured me) phenomenon. He explained that the sponsor, Wyeth, considered a BP drop of 10 points or more to be possible grounds for expulsion from the study. Mine had dropped by 18 points from the baseline measurement, Dr. S said.

He asked if I had been feeling dizzy lately, and I said no. He asked if I’d had breakfast, and I said yes. But I confessed that I hadn’t had much water to drink, and he seemed to think that might be contributing to the low pressure. He thought it would be OK for me to continue in the study, but they needed to check with Wyeth.

“We won’t let you go until we know fore sure,” he promised.

He lied. After I’d sat alone for just a few minutes, a study coordinator came in with my new supply of medications. She said that they still didn’t know for sure if I could stay in the study, but that they were going to assume that I could. I promised her that I would drink lots of water before my next visit. I also vowed, silently, to increase my intake of salt and fat.

Riding down in the elevator, I saw something else that was new to me. On a previous visit I had noticed that there was a button for the 13th floor, which indicated a lack of superstition on someone’s part, but I hadn’t noticed that the building had no 12th floor, at least not a publicly available one. That is, the buttons skipped from 11 to 13, although it took the elevator the equivalent of two floors’ worth of time to travel that distance.

Surely my newfound powers of observation, and my willingness to talk to a stranger in the elevator (and to notice what she was wearing), were signs of improved mood. How could anyone really think I was still depressed?

About an hour after I got home, the study coordinator from PsychoPharm called with the bad news: The Wyeth folks wanted me out. If I hadn’t been on a therapeutic dose of antidepressants, the news would have been devastating to me. As it was, I cheerfully agreed to go back in the next day for a final visit, which would include ECGs and more blood pressure readings (though no matter how high they were, I would still be banished from the study).

Part of me was relieved. Life would be a lot simpler without the frequent, lengthy visits to PsychoPharm. I could spend more time writing, and less time riding buses. I wouldn’t have to answer those repetitive questions about my symptoms and side effects, which I never felt as if I answered very accurately. And after I had left the study, one of the doctors would prescribe a known quantity of a known drug for me, unless I wanted to go back to being a chemical-free emotional wreck.

By the next morning I had made up my mind to stay drugged, at least until I finished my project of researching the research biz. Judging from past experience, it seemed unlikely that I would manage to drag my unmedicated self from a bed of hopelessness and lethargy every morning to continue work on such an ambitious task.

Back at PsychoPharm, Nurse D took my last blood pressure readings for the study, and they were as low as the day before. Then she did the three ECGs, as on Visit 2.

“I’m going to lay you down here,” she said. “Is that correct?”

I assured her that it was. Then I started to wonder: What if she was so annoyed by my grammar snobbery that she had falsified data in order to get me removed from the study? Even if there were no malicious intent, it was certainly likely that one person’s readings could be inaccurate. You would think that if they were using the data to make an irrevocable decision—and one that could reflect poorly on the sponsor’s product—they would seek a second opinion from someone other than the person who did the initial reading, even if the protocol did mandate that the same person do the readings each time.

I meant to ask about the possibility of letting someone else have a go at getting a reading, but I forgot to mention it to Dr J in the subsequent discussions about which drug to put me on. Also, I remembered that in the oxycodone study my low blood pressure had practically gotten me disqualified. So I dismissed Nurse D’s revenge as a mere paranoid fantasy.

Next I saw Dr. K, who did the same inventory of my symptoms and side effects that Nurse L had done the day before. We were both perplexed by the need for this duplication (my story hadn’t changed much in 24 hours), but she said that after working at PsychoPharm for 10 years, she was used to that sort of inanity. From what she said, I gathered that nonsensical guidelines are frequently written into study protocols. Sometimes, she said, subjects who are “lost to follow-up” will return weeks later, no longer medicated, and she has to do the same inventory on them as she would if they were punctual and drugged.

I later looked up the term “lost to follow-up” and discovered thousands of articles written about the problem of losing track of patients or study subjects. Such noncompliance can adversely affect the patients’ health, but it can also mean they’re out there infecting other people. And it’s very inconvenient if subjects just drop out of sight in the middle of a clinical trial. Fortunately there are companies that specialize in locating these capricious, unreliable souls. One such firm, “OmniTrace—The Patient Locate Experts”—promises on its Web site that it “will maximize clinical trial success” by finding and returning the reprobates.

After Dr. K, I saw Dr. J. We talked about the pros and cons of the various antidepressants on the market. I had done a little research the night before and found that one drug, Serzone (nafazodone), seemed to have the fewest side effects. Unfortunately it was also suspected of causing serious liver problems, so it was no longer being manufactured. The generic version was supposedly available, but Dr. J didn’t think any pharmacies actually carried it.

We finally settled on Cymbalta (duloxetine), mainly because there was a chance that I was already taking it. Even if I had been on desvenlafaxine, the drugs were similar enough that I shouldn’t have any trouble making the switch. He didn’t have any samples of Cymbalta (though he had plenty of Prozac), so he wrote me a prescription.

Lastly I saw the same study coordinator I’d seen the day before. She gave me a check for my participation through that day; I was surprised to learn that I would also get paid for a visit the next week and the week after. “Wow,” I said, “I’m wealthy beyond my wildest dreams.” She thought I was kidding.

When I turned in the prescription at my neighborhood drugstore, the pharmacist found me in the computer system and said, “So you’re switching from the Paxil?” Paxil was the only other drug I’d gotten at that particular store, so it wasn’t too surprising that she would know about it. Still, I thought it was a bit meddlesome of her to mention it. I’d never gotten that sort of nosy treatment from pharmacists at the HMO I had been with. What was especially disturbing was the knowledge that if I had visited any other store in that nationwide chain, the pharmacist would have known about every prescription I’d ever gotten filled at any other of their stores. They claim that this is for the customer’s good, i.e., that we need pharmacists to help us avoid unsafe drug combinations, but I think it’s mainly to remind me—and, more importantly, themselves—that they know more about pharmacology than I do.

The rise in paternalism on the part of pharmacists seems to have coincided with a decline in the amount of professionalism required in their jobs. The more pre-packaged medications they have to dispense, and the more laundry soap and coffee filters they have to ring up, the more they seem to feel a need to assert their professional identity by being busybodies. (In other countries druggists apparently sell only drugs and related medical supplies. As a French pharmacist told Michael Moore in the film Sicko: “I didn’t train for that many years to be selling detergent.”) Ironically, the increase in paternalism has also paralleled the increase in the numbers of female pharmacists. So maybe it’s more a case of maternalism. After all, it’s more often our mothers than our fathers who take care of our health needs and keep track of what medications we take.

Dr. J had told me that Cymbalta was very expensive. Handing over a $25 copay, I once more berated myself for giving up my job and health plan. Later I was grateful to have any insurance at all: I looked on the Web and saw that the discount retail price for 30 capsules was about $113.

I was supposed to start at 30 mg per day and stay at that dose until my next visit, a week later, even though the lowest therapeutic dose is 60. After two days I felt myself sliding back into the morass of melancholy, so I doubled the dose.

Halfway between visits Dr. S called to see how I was doing. I told him I had upped my dose, and he seemed OK with that, but he said they wanted to take some more blood from me, because a test they had run showed that I had an elevated potassium level.

The technical term for excess potassium, I learned, is hyperkalemia. Its main effect is reduced kidney function. Good sources of potassium include fish, potatoes (with skins), and bananas, all of which I’d eaten the night before the blood draw. I hoped that if I avoided those for the next few days, I would have a clean blood test and could stop worrying about kidney disease.

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