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Both Sides Now
Many Paths Bring People to Research

By Sue Gibson

October 2001

Why I Work in Research

In U.S. hospitals, nurses keep medical records in fairly understandable English -- well, maybe more Latin than English -- but despite the jargon, a patient's story is told with words. Research nursing is different. Research medicine has its own system of numerical codes to account for almost every conceivable medical event that a patient might experience while on a study. Every ache, pain and rash, every drug consumed, every lab test blip, whether related to HIV or not, has to be carefully coded and recorded for as long as a participant is enrolled. It's the perfect job for the hopelessly anal-retentive. That's why I love it.

A good research coordinator has to be incredibly conscientous about details when preparing for a patient's visit, while meeting with the patient, then just as painstakingly thorough about doing the paperwork afterward. Everything recorded goes into the computer at the data center, where it is checked for consistency. For example, if someone in an HIV trial has a motorcycle accident, the date of the patient's back injury and lacerations must coincide with the dates that antibiotics and pain medication were given. If it doesn't, the computer spits it out and a trial monitor asks for clarification at her next scheduled visit. That's why everything must be put into the file while it's still fresh in the mind.

It took me many years to discover research. When I graduated from nursing school in 1980 there was a shortage of nurses and we had our pick of jobs. I decided to keep working on the internal medicine ward of the big-city public hospital where I'd received most of my training. We dealt with organ failure, autoimmune diseases and a wide range of non-contagious infections; the variety made the work interesting and challenging. But I especially liked being able to give care to people who couldn't afford to be treated by the other hospitals in town. Our hospital rejected no one.

After a couple of years, I moved to the renal transplant unit. Transplanting kidneys involves artificially inducing immune deficiency with drugs in order to prevent tissue rejection. On this ward I became familiar with several unusual infections such as pneumocystis carinii pneumonia (PCP) and cytomegalovirus (CMV) that transplant patients often came down with when their immune systems were suppressed. Oddly, we started to hear that on the East and West coasts, certain non-transplant patients were also developing these rare infections. At first, the "gay plague" that was terrorizing San Francisco and New York seemed remote. But soon, doctors began talking about the "4H"s that seemed to be susceptible: homosexuals, heroin users, hemophiliacs, and Haitians.

Since I had several gay male friends, I paid close attention. One friend in particular started to develop certain suspicious symptoms such as enlarged lymph nodes, shingles, and weight loss. Despite my alarm, common sense told me if this syndrome was only showing up in these specific populations, then it was probably not spread by casual contact. So when I heard that nurses had left meal trays outside the door of a patient with Kaposi's sarcoma, I transferred back to internal medicine. I welcomed the opportunity to dispense care where it was so clearly needed and I wanted to learn more about the syndrome that was still being called GRID (gay-related immune deficiency). Within a few years the syndrome had a new name, a causative virus had been identified and many of my friends and acquaintances had tested positive. Sometime during that period, I too seroconverted.

I worked on the internal medicine ward until 1993, compulsively keeping a list of the names of my patients who had died. When I finally decided to make a change, I took a job at a small outpatient infusion company run by two women, one of whom had lost her brother to AIDS. But when HAART came along bringing the miraculous "Lazarus effect" in 1996, that business began to fail and I cut back to working just a few part-time hours per week.

One day the director of a community-based organization where I volunteered asked me if I could come over and "help out" in their small research clinic. I agreed, though with some hesitation, since I knew nothing about research nursing. The clinic had been contracting with pharmaceutical companies to conduct Phase III drug trials, but after a period of downsizing, only one research nurse remained. I jumped right in, learning the ropes from him and from the site monitors sent by the drug companies. Before long I realized I'd found heaven. I loved everything about research! Not just because I'm naturally obsessive about details, but also because I rediscovered the joy of providing people with cutting-edge treatments, lab tests, and medical visits -- at no cost to them! Plus, the new drugs were working. People looked and felt better. It seemed research was finally paying off.

Entering the world of research during the advent of protease inhibitors also meant that my contact with the dying diminished. Fewer people with HIV were getting desperately sick, and the volunteers in the trials I was coordinating tended to be at earlier stages of their HIV disease. I was thankful and excited to be a part of something that had the potential to slow or possibly stop the devastation that I'd seen so often in the past.

It was only later, after I learned that resistance develops when inadequate doses and drugs are given, that I realized with horror I had been complicit in decreasing some people's options by doling out each new drug, one at a time, as it came on the market. I still have a lot of anxiety when I imagine that something we learn in the future might tell us that something we're doing now is wrong.

After about three and a half years in the little community-based clinic, I moved to the infectious diseases clinic at a larger, busier university medical center, which is where I work today. Though I ended up in research by accident, it feels like a more honest place for me to be. Instead of saying, "Take your medicine; it's good for you," I can comfortably tell people that, "this is a new product or a new combination and we don't yet fully understand what the risks and benefits might be. Thank you for helping to find out."


Why They Volunteer

Over the years I've learned that people choose to participate in research studies for many kinds of reasons. I recently got in touch with some former and current "lab rats" to ask them about their experiences. No research study can benefit everyone, but in general I've found that when people are well treated and they understand the risks, they have had positive experiences. Even so, not everyone had an easy time of it.

Mike

Not a volunteer in the strictest sense, Mike was barely a teenager when he began taking walloping doses of the only AIDS drug available at the time, AZT. He didn't tolerate its toxicities very well and had to have repeated blood transfusions. A few years later, he enrolled in a trial and started taking ddI. This was when it came in a packet like Carnation Instant Breakfast.

"I remember the ddI was extremely disgusting," he recalls. "Almost so bad that I'd rather die of AIDS than take it! I remember throwing up the ddI most of the time, but NOTHING was as bad as those high AZT doses.

"I don't really remember much from around that time. From the age of 15 to 21, everything is really jumbled -- I guess it was a period of stress or something," he laughs.

"It's never comforting knowing you're a guinea pig but it would be nice to be informed why certain drugs smell like gasoline and make your mouth numb. I understand the contribution of drug trials, but I don't like taking these drugs. Of course, nobody does."

Mike can't forget the role the pharmaceutical companies played in distributing blood products to treat his hemophilia during the years when HIV was clearly in the blood supply. He also recalls how the distributors and the FDA remained silent. "I feel completely helpless relying on drug companies that seem like they have had more experience trying to kill me than trying to help me. It's like my health just doesn't compare to the value of their stock."

Mark

Another experienced research participant I spoke with has a long track record of helping others in the HIV community. For Mark, joining a research study seems to have been a natural extension of his volunteer instinct.

The first clinical trial Mark participated in investigated treatments for staphylococcus infection. "I was just recovering from a surgically caused staph infection. [The principal investigators of the study] came to me and said, 'We don't want to pressure you, but...' They asked me to please consider their study. [Ultimately] the study was discontinued. I still don't know if I was getting the real drug or the placebo."

Even so, when asked if he felt the experience benefited him, Mark replied, "Yes, I think so. If nothing else, I was contributing to the gaining of knowledge. Participating in studies is one small way I can [pay back] the privilege of being taken care of by the medical community. And it takes studies to find answers. Information is power."

While altruism is a remarkably common, yet undervalued, motivation for participating in research, the best match between subject and study comes when the research addresses an unanswered question that will not only help society, but can help the volunteer's situation as well.

Currently Mark is in a trial to study the usefulness of phenotypic resistance testing in constructing treatment regimens. He needed to switch drugs because of virologic failure and because of toxicity. "One of my drugs was destroying my liver. They ran a phenotype and found out [my virus] was resistant to every [antiretroviral drug] out there. [They found the least resistance] to two drugs and they put me on those. And I'm on open-label tenofovir. But this study [continues] whether I'm on meds or not."

Mark feels that he is benefiting from this trial as well. "They found a combination that hopefully will be working. I don't go in for my first labs [for a couple of weeks yet]. I'm assuming they'll be working! I believe in the theory of positive thinking."

Participation in research doesn't take the place of comprehensive medical care. Although the principal investigator of a trial is, on occasion, required to examine research volunteers, that physician is not directly responsible for medical issues not related to the study. Study participants need to keep seeing their primary care providers on a regular basis. A big part of the research coordinator's job is to ensure that there is a flow of information between providers and the investigators. For instance, lab results collected for the study can be shared with a patient's provider at no expense to the patient, his insurance company, or to federal Ryan White Care Act funds. When the protease inhibitors first appeared, the reimbursement issue was a big incentive for many people to join trials, especially those who lacked insurance or were afraid to use the insurance they had. With the various AIDS drug assistance programs (ADAP) in place, that's become less of a motivator.

Then as now, a major incentive for joining a study is the hope of gaining access to an experimental drug before it's approved. But this is never a certainty. Since research studies need to create a difference between how groups of participants are treated, no one in a randomized trial can be guaranteed access to a particular regimen. For people with limited choices, expanded access safety studies may offer a better shot at getting a desired experimental drug. Unfortunately, expanded access programs are rarely large enough or started early enough to fully meet everyone's need for new treatment options.

Time and again though, research volunteers often say that the most important health benefit they receive from being in a clinical trial -- over and above the value of an experimental drug -- is the close and careful attention they get from the research staff. As Mark pointed out, "The sheer fact that I'm on a study, I feel I get closer medical attention, and for that I'm very grateful. To be on a study is actually easier for me than going to my regular doctor -- it's less stressful. I'm not in the same waiting room with the mass of people going to see the clinic doctors. It's almost like you're getting VIP treatment."

As is evident in the next case, joining a research study can open doors to a quality of care unimaginable at a local clinic.

Gerri and Jason

Gerri was first alerted to her own HIV status when her son, Jason, was diagnosed at three months of age in 1989. At diagnosis, Jason's physician referred the family to several larger cities in a quest for care, since AZT was not available for babies at that time. Jason was unsuccessfully screened for three studies before being enrolled in a trial at the National Institutes of Health (NIH), in Bethesda, MD. He finally received AZT oral suspension, his prognosis improved and he lived for two and a half more years. He participated in a second trial that, as Gerri recalls, involved an IV pump, but this did not help him. "It's the luck of the draw," postulates Gerri, "Some things work and some things don't." With pride, she says, "Jason was a pioneer. At least we had hope; at least he had a chance. We learned a lot about what [medicinal therapy] can do and what it can't."

In 1990, while staying with Jason at Children's Inn, a home-away-from-home for children being treated at NIH, some of the other mothers suggested that Gerri look into NIH trials being conducted for adults. "At the time, I was just on AZT and was getting anemic and tired. I had no energy, wasn't looking good, and was losing weight. I checked into a ddI trial and was accepted."

The ddI product was the same stuff Mike took -- a powder she had to mix with four ounces of water. "I mixed it with warm water because it seemed to dissolve better and I took it on an empty stomach. Carrying it back on the plane, I had two huge boxes of ddI. I didn't want to check it; I wanted to have it with me."

Gerri believes the research benefited her: "Most definitely. My blood work [improved]." She feels that the extra medical attention she got by flying to NIH every six weeks worked to her advantage although it was tough. "The travel was draining me. It was exhausting, but I would say it helped me because they would collaborate with my physician.

"There's the social part of it, too. Most of the people I met were men, and they were gay. It was a lot of fun. I enjoyed seeing the same people who were on the same schedule. We learned from each other. I got to realize that I wasn't alone. It was very important for me to know that I wasn't going through this by myself. Some of their stories were actually worse than mine, [with] the discrimination they had seen. We looked each other up when one of us was sick, or one of our kids was sick or had died."

But when ddI was finally approved, her support system ended. "The ddI trial was discontinued due to lack of government funding. They decided not to do any long-term trials; they were only going to do short-term studies. Videx was approved by then, so I could go back home and be seen by my doctor and receive the same thing. But I missed the adventure; being tied down at home as the caregiver, it was my one chance to escape and have fun. I was working as a peer educator at the local AIDS foundation and my brother was dying [of complications of AIDS], so I lost most of my contacts. I was very upset, knowing that I wouldn't see my [NIH] friends anymore -- the health care workers in addition to the patients. I felt I was losing family members."

Gerri later joined another trial in her community. "I had oral hairy leukoplakia and I became a participant [in a trial] to treat that. I liked it because it was herbal, and it worked."

She also entered a major pharmaceutical study: "I tried all the approved drugs. The last trial I participated in was Kaletra. I'm still on it and my viral load is undetectable and my T-cells are on the rise. Although the virus is not progressing, I am seeing some side effects from being on a triple combo -- 'protease paunch' and my veins are prominent."

Yet she still has reservations about the kind of studies she would feel comfortable with. "I would only participate in Phase III trials; I wouldn't have the guts [to volunteer for earlier phase trials] unless I was desperate. Right now my viral load is undetectable for the first time in my life so I wouldn't want to risk that . . . and I have more of a reason [to be careful] since my daughter has been born."

Gerri's two-year-old daughter, Alaina, has been a trial participant, too. "When she was born, she was given a one time dose of nevirapine, but she continued taking oral AZT [until they knew she wasn't infected]."

Gerri is open to joining other research studies in the future if they'll have her. "There is a Serostim trial going on, but they don't provide transportation and they say I don't have enough wasting. It's very frustrating when trying to enroll in studies because they only want people who aren't too healthy or too sick. Mainly they want more healthy people in the trials because if you have healthy people, you're probably going to have more promising results than if you have sick people.

"The other frustrating thing that I've seen related to clinical trials is that there are far more men participating than women and someone needs to take a look at why. I suspect that women are more in the caregiver kind of role. They make sacrifices every day, taking care of their husbands, their family, their children, and they always put others first."

I asked Gerri if she had ever been in a study that didn't benefit her. "No, trials work to a degree. After a while the drugs lose their efficacy. I envision them as lily pads, and when one starts sinking, you hop on another one before it starts sinking, hoping one day that you reach dry land. I think subjects know that they are human lab rats and that [no one can] guarantee that the trial is going to help. Hopefully people won't look at it as a guarantee, because nothing's guaranteed in life except death."

I asked Gerri where she thinks she would be today without research. "I wouldn't say there's no doubt, but I probably would have been dead. Research hasn't cured me, but it has given me my life back."


Why We Keep Showing Up

These stories illustrate a few of the ways that research has affected and has been affected by real people living with HIV in the United States. Mike, Jason, Gerri and Mark represent only a snapshot of those who have extended themselves -- sometimes in desperation, sometimes when there were less risky choices -- to help discover what a new therapy has to offer. They have taken risks, and as with all things uncertain, sometimes they have benefited and other times they haven't. But, like volunteers in most trials, they made a contribution to the body of knowledge that has brought HIV treatment to its current state and will hopefully continue to provide better options.

As for me, I'm continually impressed with the dedication people demonstrate when they volunteer for clinical trials. They show up for research clinic visits in addition to keeping appointments with their regular health care provider. They sit patiently while I ask an endless number of tedious questions and, in most cases, collect multiple tubes of blood. Together, we wait anxiously for lab results and have an ongoing dialog about whether this study is helping. Though we rarely say so, I think we understand each in our own way that helping to move research forward is the best chance we have to make sure no one else has to go through what Mike and Gerri and Jason did.


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