Are Ordinary People Risking Life for Science?

For Bob Helms, a day at work can literally be a draining experience.

"I've gone home with ugly track marks on my arm that take a week to heal. I've fainted, I've passed out for eight hours afterward," said the 44-year-old Helms. "It can be dreary and very boring."

Helms is a self-described human guinea pig who, for seven years, has taken money in exchange for his time, blood, urine and sometimes feces as a paid volunteer in drug research trials.

Helms has written a book called Guinea Pig Zero about the experiences of human guinea pigs in clinical trials to come out this May. He may sound like a hero of sorts — as someone who braves the uncertain effects of new medicines to help researchers ensure they're safe for future patients.

But he's clear his motives are not selfless.

"I do it because it's a way to catch up on my bills and earn a little," said Helms, who earns $150-$400 a day for his contributions.

Drug Testing ‘Terribly Flawed’

The real heroes, and the ones most vulnerable to risk, Helms claims, are those who are already sick and undergo clinical trials at their doctors' advice, out of desperation, or even unknowingly.

Sometimes the trials help save lives — like Tom Christerson, 70, who just became the longest living recipient of a totally implantable artificial heart after six months with the device. But occasionally, they jeopardize them, as what happened last month when 15 Alzheimer's patients suffered brain inflammation after taking an experimental vaccine.

The failed Alzheimer's vaccine trials, conducted by the Dublin-based Elan Corp., has caused bioethicists to revisit the drug testing system that past mishaps had already revealed as flawed. Despite some reforms, many conclude the system still poses serious risks to both healthy test subjects like Helms and ones seeking treatment.

"It's kind of like democracy," said Paul Root Wolpe, a sociologist at the Center for Bioethics at the University of Pennsylvania. "It's terribly flawed and problems fall through the cracks, but it's still a better system than all the others."

A Long Road to Market

The process goes like this: Once a drug company has formulated a new drug and tested it on animals, they must then test the drug in a series of human trials. Phase I trials test the safety of the new drug on a small group of healthy volunteers (like Helms). Phase II tests the safety and effectiveness on a small group of sick patients. And phase III trials test the drug on a large group of patients.

Before conducting any drug trials all publicly funded and some privately funded researchers must submit their projects to an Internal Review Board, or IRB. The IRB then evaluates the risks and protections for future trial subjects. Publicly funded projects must meet federal standards enforced for clinical trials as outlined by the Food and Drug Administration in 1991.

Some argue all clinical trials — public and private — should be held to these federal standards. In fact, a bioethics counsel operating under President Clinton's administration recommended this step five years ago but it hasn't yet been taken.

"There's a great deal of commercial research that isn't regulated at all," said Beverly Woodward, a medical ethicist at Brandeis University who has monitored the system.

But past trials have shown even enforced government standards can't prevent tragedy.

In 1998, 24 critically ill patients died after being given a blood substitute without their informed consent. The FDA had recently granted approval for companies to conduct clinical trials without informed consent for certain emergency room products. Baxter Healthcare Association was trying to glean data for their product, HemAssist, but when results showed more patients died in the HemAssist group than in the group receiving donated blood, the company stopped the trial.

In September 1999, 18-year-old Jesse Gelsinger died after undergoing experimental gene therapy treatment at the University of Pennsylvania. Gelsinger had suffered from a rare liver disorder, but had been relatively healthy before undergoing the test trial. His father claimed the researchers failed to reveal all the risks involved in the procedure.

"I encouraged my son to do this," Paul Gelsinger told a Senate Subcommittee on Feb. 2., 2000. "But I wasn't given all the information."

And last June, Ellen Roche, a healthy 24-year-old woman, died after inhaling a drug known as hexamethonium for a drug trial at Johns Hopkins University. An investigation later revealed the consent form Roche had signed didn't mention that the drug had never been approved for inhalation.

Children and Trials

Wolpe explains doctors on IRB's are often underpaid and under qualified to make sound judgments. Since drug trials often involve very specialized fields of medicine, risks can be overlooked during assessment.

Woodward is particularly concerned about children in drug trials. She points out a 1997 FDA mandate encourages drug companies to test their products on children. The mandate rewards companies that do so by extending their patent on a drug by another six months — a term that can be highly profitable for companies selling a popular product.

"It's a very dicey issue because you're dealing with people who cannot really give their informed consent," said Woodward.

But researchers counter that parents are very capable of making such delicate decisions for their children and that review boards pay extra attention to safety when considering tests on children.

"The parents are made sure they understand all the possible benefits and risks and are encouraged to ask questions," said Laurence Greenhill of the New York Psychiatric Institute. Greenhill is principal investigator for a clinical trial testing the use of the psychiatric drug, Ritalin, in pre-schoolers.

Greenhill adds that if clinical trials do not include children, then doctors will never have access to research to guide their treatment of juveniles.

Money and Judgment

One skewing factor in the clinical trial system, Wolpe argues, is money. He's concerned that healthy people like Roche might overlook the risks involved in a particular experiment if the pay is high enough. Helms is clear that pay is a main factor when considering which trials to enter — he won't work for less than $150 a day.

"The IRBs determine at what point are you using money to defeat people's better judgment," said Wolpe.

Money might also compromise doctors' judgments, he says. Drug companies often pay doctors for every new patient they recruit to undergo drug trials.

But John Plachetka, president and CEO of Pozen, a Pharmaceutical Development Company based in Durham, N.C., claims this pay is only designed to cover the costs a doctor adopts when entering a patient in a trial.

"The money is for their giving up time they could be using for running their practice," said Plachetka. "If they don't spend the time discussing all the risks with their patients, we're not interested."

When Trials Work

Recently patients have begun bypassing doctors and seeking clinical trials on their own through Web sites such as CenterWatch.com and ClinicalTrials.gov. These sites serve to connect prospective patients directly to drug companies seeking subjects. Once patients find drug trials they think could help, they then seek advice from doctors and researchers about whether they qualify and might benefit.

The method worked for Ted Wiles, who used the Internet to find a clinical trial for his stepdaughter, Taylor Nicholson, last year. Nicholson was suffering from a rare childhood brain stem glioma cancer. Nicholson's mother explained the choice to enter her 6-year-old daughter in the drug trial was easy.

"We were willing to try everything," said Tina Wiles, Taylor's mother. "We had taken her to faith healers, we had tried natural herb medicines. Even if this treatment only prolonged her life by six months, we decided it was worth it."

Today Nicholson is back at school and her current tests show no signs of the cancer.

It's hopeful stories like Nicholson's that drive the drug trial process to begin with. As Plachetka says, "It's absolutely tragic when mishaps occur, but somebody somewhere has to be among the first to take a drug. Otherwise we'll never know what works and we'll never get new drugs."

But Helms, who recently lost touch with a friend who he says became mentally unstable after volunteering for a series of psychiatric drug trials, argues the risks don't need to be so high.

"We're offering ourselves to science, even though no one ever hears about our contributions when the papers are published," said Helms. "We deserve better protection."

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