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Testing new drugs in humans for the first time is tricky and potentially dangerous. Researchers spend years performing safety and efficacy tests on animals before handing a pill to a human, but what works in mice or rats does not always work the same way in us. No one knows for sure what will happen the first time a person swallows a new remedy for Alzheimer’s or diabetes.

Most drugs not given to gravely ill people are tested on volunteers who are paid up to thousands of dollars to participate in studies. Check out a newspaper in a city with a major medical center, and you’ll see dozens of ads asking healthy people to participate in trials testing new meds for cash.

Trial managers are required to follow safety protocols, and most volunteers emerge unscathed, though injuries and even deaths do happen. In Britain earlier this year, a group of healthy men were given a new drug that had shown great success in boosting the immune system of mice. Unfortunately, when the volunteers took the drug, their human immune systems went into an almost immediate overdrive that caused their organs to swell and nearly killed them.

With 2,000 compounds in human trials in the United States and more coming all the time, the demand for test subjects is fierce–which is why some trials pay big bucks. (This is also why many pharmaceutical companies are moving overseas to India, South Africa, and Eastern Europe–a topic to be covered in a future blog.)

So, who are these volunteers in the United States?

According to findings in a recent article in the journal Clinical Pharmacology and Therapeutics, test subjects are mostly poor people willing to take a risk for what would seem to be easy money. The study, written by ethicists at Johns Hopkins, discovered that most volunteers are not only lower income, but are also serial volunteers. That is, they join one trial after another. A few of them even join more than one at the same time, a violation of trial rules that can endanger volunteers. Mixing experimental drugs can also skew the trial’s results.

According to an article that ran in the Baltimore Sun this week,

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.

Bottom line: as more new drugs enter human trials, a crisis is brewing. On the one hand, using cash to lure poor volunteers to test risky drugs, which, having only been tested in lab critters, may fail to predict reactions in humans, is clearly exploitive; on the other hand, there is no substitute for testing drugs in humans.

In the future, computer simulations to test drugs in virtual human systems will be helpful; so will designing tests to further ensure safety. For example, giving very low doses to the first human guinea pigs can lessen negative reactions–something that could have helped prevent the United Kingdom debacle. Perhaps volunteers should be more carefully screened to make sure that they are not on other trials, although this is next to impossible if a volunteer lies.

As for the payments, the problem of poverty and the desperation to make money that drives people to take health risks are much larger than the issue of drug testing. Yet an industry that is creating products to help people, not to mention the physicians and clinicians who are running the trials, need to address the issue of drug testing for cash and come up with creative solutions, if possible.

There need to be more studies about who is volunteering for drug trials. The Hopkins study surveyed only 60 volunteers. A larger sampling is needed so that researchers can learn if the findings of this study hold up.

I am curious to know if anyone reading this has any thoughts or ideas about how to solve the dilemma of how to attract human volunteers for drug trials without resorting to payments that seem to prey on the poor.

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Tagged: drug testing

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