Apr 25, 2008 11:07 pm US/Eastern
Clinical Trials May Give Patients False Hope
BOSTON (WBZ) ―
Our life expectancy has almost doubled in the last 100 years thanks to countless new drugs. Those treatments and the cures of the future wouldn't be possible without the human volunteers who test them. But now some experts worry those volunteers may be paying too high a price.
Six years ago, Barbara Holtz found out she had an aggressive from of breast cancer.
"It's the most horrific piece of news that can come to a person," she said, thinking back to the day she was diagnosed.
That's why Holtz jumped at the chance to take part in a clinical trial testing an experimental cancer drug.
"I wanted to do everything I could to fight for myself," she said. "I had to be a warrior."
But some medical ethicists say Holtz wasn't fighting for her life, she was risking it.
"Mostly research doesn't work, and often times research is harmful," said Dr. Michael Grodin of the Boston University School of Public Health. But you won't find that warning in the constant barrage of ads in newspapers and on the radio. There is even one study looking to test a vaccine on infants.
Dr. Grodin is concerned that many patients can't see the difference between research and therapy.
"People start to believe that research is really treatment," he said.
Grodin says drug companies are taking advantage of sick people who are desperate for a cure. "The drug companies are not out to save the world," he said. "They're there to help profit their shareholders. That's the fiduciary obligation in fact."
Kenneth Getz founded an organization designed to encourage more people to take part in clinical trials.
"It's very fashionable to demonize the pharmaceutical and biotech industries," he said. Getz also wrote a book called "
The Gift of Participation". He believes people like Barbara make an important contribution to society. "Without the patients who are in clinical trials, we don't have medical innovation, we don't have new therapies," he said.
Researchers also need healthy people to take part in clinical drug trials. Cash strapped college students are often enticed by the stipends which can sometimes add up to thousands of dollars. Nineteen-year-old Traci Johnson enrolled in a trial to help pay her college tuition. She hung herself while testing an anti-depressant. Traci had no history of depression.
Getz admits there are risks, but he says the complications are rare and volunteers sign consent forms that fully outline the risks involved. They are also told they may only get a placebo.
Barbara Holtz prayed that she would get the experimental drug and that it would save her life. "Ultimately, it came down to a leap of faith," she said. The drug in Barbara's study is now part of standard treatment for many breast cancer patients. Doctors don't know for sure if it saved her life. But Barbara believes that it did.
Getz admits not everyone is going to be as lucky as Holtz, but he thinks that ethicists are too critical of clinical trials. "Who would deny a patient who has exhausted all other options the consideration of a clinical trial as a potential for hope," he said.
But Grodin says people like Holtz are the exception and not the rule and for many patients, clinical trials are simply false hope.
"People need to understand that it's not being done for them, it's being done for society at large," he said.
Grodin believes patients would be better off getting the placebo, because the drugs can cause serious side effects. "You could get sicker, in fact people have died," he warned.
It's a chance Holtz says she wouldn't hesitate to take again.
Visit
www.ciscrp.org or information about the nonprofit founded by Getz to encourage participation in clinical trials.
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