No Love for the Lab Rat

A Rodent's-eye View of Clinical Research - Part One of Two. Names changed, otherwise pretty damned true.

I was high as shit. 

I had just taken the experimental drug CX-8998 MR1-prime.

In the dayroom at Medstarco, a clinical research unit (CRU) in Arizona, a wave of dizziness washed over me, followed by a wave of fear. It was experimental. I could die. I had signed a contract saying that. 

Page one of the 27-page contract said, 'A phase-1, randomized, double-blind, placebo-controlled, parallel-arm, multiple ascending dose study characterizing pharmacokinetics, safety, and tolerability in healthy adults.'

That was us -- healthy adults, aka lab rats. 

Our job, nominally anyway, was to report 'adverse events' (A.E.'s) --You know, that 'side effects may include' list they speed-read after drug ads?

I walked through the crowd of participants, primarily non-English-speaking girls watching T.V. 

“Estas tan boracho como yo?” I asked. -Are you as drunk as I am? I couldn't think of the word for 'high.' Some shook their heads 'no.' That's big here —not saying anything. This study paid 10K; no one wanted to mess that up. 

These CRUs say they want honesty, but where the Oxycontin hits the hippocampus, they don't. They rush drugs to market, pretending to be disinterested. 

According to Dr. Ben Goldacre's book Bad Pharma, industry-sponsored trials are four times more likely to yield favorable results for Big Pharma than university-funded studies. Four times. What are the odds of that? 

I found a slovenly nurse named Tim.

"It feels like a mixture of ecstasy and mushrooms, not that I know how that feels, but I know how that feels," I reported, joking. "Not unpleasant, but intense. And that death threat in the background ruins the buzz a bit."

Tim looked alarmed. "Do you have a history of drug abuse?" 

"Of course not," I said. "But I'm from the 1960s; we tried things." 

The truth was, I was coming up on another sobriety birthday, and I was proud of that. Some participants look like they spent their whole lives in bars. It's not like Medstarco checks with A.A. We lie about our histories. 

I wondered if I'd have to start counting my sobriety date over. If I lived. 

This was my 11th trial in 5 years. Getting paid $200-$500 daily to lie around with a computer was a dream for a writer. 

When friends ask how risky it is, I've always told them Big Pharma urgently wants to get the drug to market so they can have a monopoly, so they dose conservatively. I never experienced more than a bit of diarrhea once in Baltimore, but that could have just been Baltimore.

Tim, the nurse, checked off a few more boxes and said, "Okay. Tell us if it gets worse. Don't discuss your A.E.s with other participants." 

"Oh. Don't ask, 'Are you high?' like I just did?" 

"Exactly, because asking someone might suggest it to them." 

There's some truth to that, but this was beyond suggestible. I was high-high.

I went back to my room and my contract. The medication was a central nervous system depressant for tremors. We were taking it now so Pazco Pharmaceuticals would know what to tell your Parkinsonian or Epileptic grandparent later.

I had only half-read the list of possible side effects found in previous studies because, well, 10K, and I knew what they all said: possible nausea, headaches, etc. 

CX-8998 was tested previously in animals and people with schizophrenia. 

Now, I damn sure know schizophrenics aren't reliable: 'Hey, Napoleon Bonaparte! How's that headache today?'

And animals can't tell you they are high. Researchers might have suspected something when the bunnies tye-dyed their fur and staged a production of 'Hair.' --Google it, youngsters. 

Detra, a black lady with blue hair and a mother of three I had befriended on the bus ride from our COVID quarantine to the facility, made a face at me from her cot. 

"What?" I asked.

"I'm fucked up, are you?"

"Uh, hunh." I nodded my helium balloon head. 

We're not supposed to talk, but we do. Twenty-five girls pent up in five dorm rooms --you'll get a little chatter. We're high for Chrissakes.

Jasmine, a former stripper, just back from Mexico, where a doctor gave her an ass the size of a shooting target, sashayed up to Detra and me with a mischievous grin. 

"Let's walk," She suggested. Walking in big loops around the facility was the only exercise allowed. We put on our sneakers. 

"I am so high!" Jasmine whispered while walking. 

"Never have I taken a drug this potent in all my years." Detra's head moved from left to right.

"I know, right?" Jasmine's eyes widened. "And they're doubling the dose every week for a month!"

"Unh unh. Detra wiped a long fingernail across the space in front of us. No one's grandmother ought to be taking this." 

Just then, a frail woman wearing a gold cross, fell to the ground. A friend caught her arm and laid her on the industrial tile.

Staff gathered slowly. 

"Anyone taking vitals?" Jasmine asked.

I rushed to the office. 

"Um, there's a girl down in the hallway," I told a woman wearing PPE.

The soulless eyes looked past me, and words came out of the face mask.

"If you experience adverse events, report them. Do not discuss them with others."

I can't stand these company girls.

"Well, you might want to hurry up 'cause it's a little hard not to discuss a girl passed out on the floor.”

"It was most likely a vasovagal reaction. You all had blood taken after dosing. Sounds like vasovagal to me."

"Does it? That sounds like outstanding science to me." The sarcasm moved my mouth. This drug made me forthright. I should have reported that as an A.E.: 'overwhelmed by a rowdy and delightful insouciance.' 

I talked to the girl who fainted, now in her bunk. I told her in Spanish that everyone said it was the blood draw. I asked what she felt in her heart. Was it the blood draw or the drug?

"La droga," she said, closing her eyes.

That night, while trying to sleep, hallucinations appeared behind our eyelids. 

"This is some serious mind-altering, psychotropic bullshit," Detra said.

Jasmine got three styrofoam cups of hot water and put camomile tea bags in each one.

"You outlaw! How did you smuggle in tea?" I asked, taking a cup.

"I bought a triple E bra and filled it with all sorts of contraband."

Detra showed us the oversized scrunchy that held all her braids on her head. On closer inspection, it was like a fanny pack filled with instant coffee, essential oils, birth control pills, and chocolate.

"Ain't nobody gonna mess with a black girl's hair."

We laughed and sipped tea.

Then Jasmine shared an intriguing idea:

"In one study I did, everyone refused to give blood until they got paid more. We gotta figure out how to get this study closed down. They pay the full amount when they close them down, and the drug company doesn't report the bad study."

We pondered that, then Jasmine burst out laughing.

"Listen to my mercenary ass: 'Hey, this is dangerous! I want more money! I mean, my kids might get a dead mother, but she'll be a rich, dead mother!'" 

"With an awesome ass," I said. 

We laughed and fell into fitful, psychedelic slumber.

Jasmine grabbed my hand the next day and dragged me into an office.

"Meet Stan, the Man."

She had become friends with a staffer who would 'tell us the real deal.'

Stan was forthright for a guy who had worked there five years.

"They are keeping the bathrooms open after dosing, so there's always that," he mimed vomiting with his finger. 

"Or, they have shut down studies if many report A.E.'s, but you need ten people. If just a few people report, they kick them out."

Back in the dayroom, a brassy participant named Juliana held court with a group in Spanish.

"Don't report A.E.'s. You get kicked out if you do."

"Juliana, don't tell them that. This is their job."

"Hay que reportar A.E.s!" I yelled. 

Juliana took me aside. 

"Look, these people usually work in the fields or clean houses, just back-breaking work. Do you think they want to stand out? Hell no. They want that money. They are not going to report anything."

I told a nurse about Juliana. 

"I'd just ignore it," she said 

I started encouraging everyone, including all the LatinX girls, to report all their A.E.'s so we could get paid more. 

Tim, the nurse, had to be called in from home one night because so many were reporting. He was pissed off and scattered. He approached me and said,

"Are you Vanda? What's wrong? Are you okay?"

"Yeah, I'm okay. I'm just high and was told to report anything unusual."

"So you're not dying, good. I guess more people than usual reported."

"Yeah, well, just doing our job," I said.

"Oh, hey Tim, I am dying ... to poop."

Not pooping is a pain to report. Tim had all these boxes he had to tick.

"When did you first notice constipation?"

"I don't know. Two days ago."

"What time?"

I looked directly into Tim's bloodshot eye.

"Noon, Tim. Noon is the time of day when I think of my colon."

He didn't laugh. He took me into his office and parceled out five individually wrapped prunes. 

"Do I have to eat them in front of you?" I asked.

That's when his maverick emerged.

"Well, I don't mind bending the rules a little, but I don't want to hear, 'Tim let Vanda do it!' is all I'm saying."

Tim and I had an understanding. I shoved the fruit into my scrubs.

"Thank you. You're my hero." 

A twinkle appeared and died in Tim's eye.

Roberta was a Puerto Rican fitness instructor whose ass looked like she had smuggled two grapefruits into her orange scrubs. She was having palpitations and an abnormally fast pulse.

"You know, sometimes it's psychological," he said. I listened through the door, recording everything. 

"You mean like in my head? Yeah, no. I don't think so. My pulse was 100 bpm." Roberta replied. 

"Did you hear that?" Roberta asked me. 

"Yup." I held up my tape recorder. 

"Roberta, I googled lawsuits with this company. One hundred sixty thousand items came up, many about non-reporting of A.E.'s, even death." 

"Damn," Roberta said. "See, that's the shit that's not supposed to happen after the drug gets to market. 

I brought my computer into the day room and showed Milly, a staffer who had become my friend during a previous study.

"Look at the trouble Pazco Pharma got into with non-reporting." 

Milly ushered me into her office.

"What's your point, Vanda? She asked.

"Well, Milly, it's beginning to look like this whole industry has the integrity of pond scum. Even you said the girl fainted from her blood draw." 

Milly then decided to wow me with her vast intellect. She wrote the word 'vaso-vagal' in capital letters on paper. She slid the paper across her desk to me.

"Do you know what those root words mean?" 

"Oh, come on, Milly. Don't condescend. I know it's possible. But it's not certain."

"We believe it was a vasovagal response to the blood draw."

"Do you believe that? That's a nice belief. Beliefs are conjecture, right? 

 Milly looked hurt.

"Look, Vanda. I am here to advance science. My heart is in the right place."

The next day, I researched Pazco Pharma. I found a story about an exec murdered on a golf course. The police report said 'blunt force trauma to the head.' A doctor had died under suspicious circumstances; the family wasn't talking. I wondered if these legal drug dealers were as bad as illegal ones. 

Jasmine came up close to me. 

"Stan said they told the staff not to talk with you," she whispered conspiratorily.

 "You gotta dial back the Norma Rae thing, mama." 

A sick feeling not related to the study drug engulfed me. They would try to lose me, and I would lose the money. 

Two entities in full PPE--like science fiction antagonists --approached me. They had plastic faceguards and booties.

"Would you come with us?" 

"Who are you guys?" I laughed. They looked ridiculous. 

"We're I.T." -to be continued