The Brooklyn mother already had one son in trouble with the law. So when researchers at the New York State Psychiatric Institute said they wanted to study her younger boy to help understand what keeps kids "out of trouble," she jumped at the opportunity.
She thought they'd let her know if her son had any behavioral problems, she told the New York Daily News. And there would be some extra cash, too. The researcher proposed paying the family $125. Her son would get a gift certificate from Toys 'R Us.
She decided to do it, and so entered the ethically sensitive realm of human clinical drug trials. Little did she know at the time, the experiment would become a pivotal example of the growing weaknesses in the system that's designed to protect people who become, in essence, "human guinea pigs."
At a hearing today on Capitol Hill, four government reports will call for reforms of the Institutional Review Boards (IRB). The ethics boards are supposed to ensure the benefits of any human research outweigh the risks and that people are fully informed before they agree to join any study.
The most damaging report, subtitled "A System in Jeopardy," concludes the dramatic increase in research trials has outstripped and overloaded the IRB system; that too many research proposals are approved "too quickly" and with "too little expertise;" and that inherent conflicts of interests "threaten their independence."
In need of ethics boost
Some scientists and ethics experts contend that assessment is exaggerated, but all agree the system needs improving. "We can do more to ensure that review boards and patients are fully informed of all the ethical, legal, and scientific issues," says Belinda Seto, of the National Institutes of Health (NIH).
The IRB system, a collection of local voluntary boards made up of scientists, academics, and at least one lay person, was developed in the 1970s. At the time, 85 percent of the clinical research on humans was done in prisons. People began to question the ethics of using captive populations, says the University of Virginia's Jonathan Moreno. And then the revelations broke that African-American men were unwitting subjects of a syphilis study in Tuskeegee, Ala.
Since then, most prison research has been halted. But the number of research studies has skyrocketed. It's estimated there are now between 3,000 to 6,000 IRBs. But no one knows for sure. The government also has no idea how many human test subjects exist, although it keeps meticulous track of real guinea pigs used in medical experiments.
Dr. Seto admits that's "a rather sad reflection," but she says they are now working on a proposal to set up a central database.
Preying on the vulnerable?
There are also questions about whether IRB's are thorough enough to protect vulnerable populations. Many studies promise free health care. That can be quite a lure for the 42 million Americans without health insurance.
"The ones who have no health care can be vulnerable to the ads for free care," says Rep. Christopher Shays (R) of Connecticut, who chairs today's hearing.
Many studies also involve promising new drugs for serious medical conditions, but half of the participants may be given placebos - sugar pills - instead of a potential breakthrough cure.
But the Pharmaceutical Research and Manufacturers of America insists IRBs ensure such risks are properly explained, although it says overworked boards could boost efficiency if a national IRB were created for complex multi-site studies.
But in the New York case, the Brooklyn mom doesn't think she was fully informed of the risks or the real purpose of the study.
Her young son fasted for more than 12 hours, took several psychological tests, one dose of the drug fenfluramine, and then had his blood tested five times.
Two years later, the distraught mother learned the drug has been banned for causing heart problems in adults, and the real purpose of the study was to find predictors of aggressive antisocial behavior. Her once-outgoing son, she says, now has anxiety attacks and learning problems.
In the outcry that's ensued, the study has been questioned as racist and coercive. It's now being investigated by the NIH.
In statements, the NYSPI defends its study and notes that single doses of the drug for children are still government approved.