Medical testing of volunteers questioned

April 15, 2007|By Chris Emery | Chris Emery,Sun reporter

If you want to be a human guinea pig, there's a job for you in Baltimore.

Advertisements seeking healthy medical research volunteers appear in local newspapers, on fliers in college dormitories and on Web sites such as GPGP.net, which lists experiments worldwide.

The City Paper alone features four pages of ads involving studies on treatments for bird flu, dengue fever, West Nile virus, asthma, insomnia and other ailments. Many want healthy people willing to take experimental drugs in exchange for money -- in some cases, thousands of dollars.

Scientists say this is a legitimate avenue for seeking volunteers. Also, many volunteers sign up for altruistic reasons.

But a provocative new study by Johns Hopkins researchers suggests that the lure of substantial payments is particularly strong for the poor and uneducated. It found that low-income people were more likely to sign up for multiple experiments and volunteer for riskier studies. In fact, nearly a third of the respondents had joined in 10 or more trials.

Experts in medical ethics say the Hopkins study raises difficult questions about the way research is conducted. Scientists don't know much about the long-term health effects of repeatedly volunteering for such studies. Nor do they have a definitive way to determine if participants violate guidelines that prohibit joining more than one study at a time.

"That could pose a risk to the volunteers, and a risk to the science," said Nancy E. Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics and one of the study's authors.

The study -- a small one involving 60 volunteers, most of whom had participated in at least one study at Hopkins -- was published online last month in the journal Clinical Pharmacology & Therapeutics.

Medical researchers seeking healthy human subjects are usually conducting Phase I clinical trials of experimental drugs or devices. They are the first batch of human tests required to show the Food and Drug Administration that a new treatment is safe and effective.

In the United States, nearly 2,000 Phase 1 clinical trials are registered with the National Institutes of Health. Of those, 145 are located in Baltimore and currently recruiting volunteers.

At this early stage, scientists are trying to determine whether a treatment does any harm to otherwise healthy people -- not whether it actually works.

Typically, a small group of 20 to 80 volunteers takes a drug previously tested for safety only in animals. Researchers have attempted to predict side effects and safe dosages, but they can't be sure what will happen until people take the drug.

While most volunteers experience only mild side effects -- such as headache or nausea -- on rare occasions the experiments result in permanent injury or death.

Some experts also worry that scientists don't know enough about the long-term effects of repeated exposure to potentially toxic, experimental drugs. With no state or national registries for volunteers, there's no guarantee that subjects will wait long enough between trials. Nor can researchers spot patients who join multiple trials simultaneously.

"A lot of volunteers we talked to were crossing state lines to participate in studies," Kass said.

One volunteer who has made a small living from studies in recent years said he often meets participants from out of state. "It's a lot of money," said the Baltimore man, who requested anonymity because he worries that he will be excluded from future studies.

He said he is enrolled in a drug study that pays more than $2,000. In the past, similar sums have prompted him to wait less than a day between studies, and to join two experiments at the same time.

"I was doing one study at Hopkins, on the weekends," he said, "and then I would go to [a different one] Monday through Friday. They ask you if you've been in another trial in the last 30 days, but, of course, we would say, `No.'"

He said he worries about the possible toll on his health but noted that he made roughly $10,000 in study payments. "I'll probably go back to school once I've done enough of these," he said. "There's a price to be paid for everything."

Exactly how much risk volunteers take on is difficult, if not impossible, to determine. Some experience no side effects, while others might develop headaches, vomiting and diarrhea. In rare cases, the outcomes are more severe.

One highly publicized case in Baltimore was the 2001 death of Ellen Roche, a 24-year-old lab technician at the Johns Hopkins Bayview Medical Center who suffered lung damage and multiple organ failure after taking an experimental asthma drug.

The FDA later ruled that the Hopkins researcher leading the study had failed to get proper federal approval and had not fully disclosed the health risks to the volunteers.

Another case made headlines in March 2006, when six men suffered multiple organ failure during a drug trial at Northwick Park Hospital in London.

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