• 
• CLASS
• JOBS
• AUTO
• HOMES

Bringing drugs to market: Volunteers crucial to development process

JANESVILLE — Maureen McAfee said her part in testing medication for fibromyalgia was win-win.

Her pain eased while she took the daily oral drugs, and she felt good about contributing to drug development that could help others in the future.

"Unless you help other people, there's not much point to life, is there?" said the 73-year-old Beloit woman who retired from teaching last year. "I felt this way I was doing something that was beneficial not just for me but for other people, too."

McAfee's attitude is similar to many clinical trial participants, said Dr. Leslie Taylor, executive director of the Dean Foundation for Health Research and Education in Middleton.

"I think that people do feel kind of good about volunteering for (clinical trials)," she said. "(Participants) want to get benefits for themselves but like the idea of advancing the field for something they've suffered for a long time."

While some study participants are paid, area directors of clinical trials say they've seen only a slight increase in people seeking to participate since the economy soured.

Companies and health care organizations in the area offer several opportunities to participate in different phases of clinical trials.

Phase 1

You've probably seen ads on TV or in print inviting people to participate in medical studies and make money. That's likely for a Phase 1 study at places such as Covance.

After a new drug has preclinical data from animal testing, it goes to the first phase of trials on humans, or phase 1. Healthy volunteers participate to see how a drug reacts on a body, what side effects occur and what dosage amounts should be used.

"The idea of phase 1 studies is to ensure the drug is safe," said Susan LaBelle, vice president of global marketing at Covance in Madison. "At this point, we're not seeing if it works, we're looking to see it doesn't cause any side effects."

Pharmaceutical companies decide on the test populations, which are mostly healthy males ages 18-40, she said.

In winter, farmers participate in studies at Covance, LaBelle said. The Madison clinic sees fewer college students than most people expect.

Volunteers come in for screening, which includes a physical every time. Each participant must complete an informed-consent form, which explains the process, shares information about risks and warns about possible side effects.

"We want to be absolutely positive that they understand what they're signing up for and are comfortable with that," LaBelle said. "Their safety and their health is the most important thing to us when we're doing these studies."

Participants are free to leave the study at any time, she said.

"Severe reactions are very, very rare in the whole drug development," she said. "(But) there's no such thing as a risk-free drug. Everything has some risk associated."

Before drugs can be given to humans, the U.S. Food and Drug Administration has to review animal and lab test results and approve the clinical trial, she said.

At Covance, most phase 1 participants stay at the clinic—a cross between a hospital and hotel. During the stay, participants aren't allowed to exercise, and their diet is controlled.

Payment for participation depends on the length of stay. Participants can make a few hundred dollars up to a few thousand dollars. LaBelle recalled one study paid about $5,000 because it required a stay of almost a one-month at the clinic.

Once data from small populations indicate a drug is safe, it moves on to phases 2 and 3—"disease populations."

Phases 2 and 3

Phase 2 starts with testing drugs on patients to see if they respond as intended, Taylor said.

"It's important because we're not going to ever have better treatments if we don't study it in humans," she said. "There has to be research in patients who actually have the disease to find out whether or not the medications are helpful."

The patient is getting treatment, so the compensation isn't the same, she said. The FDA allows payment only for travel reimbursements, she said, so patients at the Dean Foundation get anywhere from $40 to $70 per visit.

If a patient doesn't have insurance, however, a trial is an opportunity to try a new drug, she said.

Most people come to the foundation through advertising, though doctors do refer patients, she said.

At the Mercy Regional Cancer Center in Janesville, most clinical trial patients come through doctor referrals, said Dr. Emily Robinson, the principal investigator of cancer clinical trials at Mercy Health System.

The cancer center focuses mainly on phase 3 trials, which compare a new treatment against the standard of care for a particular type of cancer, she said.

Getting the latest cancer treatment is often why people seek to participate, Robinson said.

At the cancer center, patients are responsible for whatever their insurance doesn't cover while on the trial, she said.

State law says insurers can't deny payment for a patient participating in a phase 3 clinical trial, she said.

Importance of studies

While some people fear they're acting as guinea pigs, participants get good medical care, Robinson said.

"Actually, it's been shown people who participate in trials sometimes have superior medical care because there are so many guidelines in what to do," she said. "So it's very controlled."

It's superior care and the latest advancements that draw cancer patients, she said.

"They feel this bad thing has happened to them, but they can make some good out of it by participating in a clinical trial and providing information so researchers can learn about better treatments," she said.

McAfee, a self-described "incredibly healthy old lady," said her motivation went beyond seeing improvement in her own conditions while in the fibromyalgia study.

"For me, it was a feeling of maybe I'll never feel the benefits of all this, but someone will, I hope," she said.

Drugs being tested could prove valuable to a wide range of patients.

Covance clinics test whatever their pharmaceutical companies request, and many of the popular drugs now being tested target cancer, Alzheimer's disease, central nervous system diseases, diabetes and high blood pressure, LaBelle said.

There's also a lot of interest in alcohol abuse, Taylor said. The Dean Foundation is planning a study in coming months on medications to control drinking.

With so many possibilities, studies draw a good cross section of people, LaBelle said.

"We really couldn't bring any new drugs to the market without people willing to come in," she said.