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An artificial heart pump, part of a clinical trial, keeps Thomas Mator of Brownstown Township alive.Web spreads the word on clinical trials
Federal money funds more research; Internet helps round up patients from across the country.
Daniel Myers talks with Ann Valden of Ann Arbor about a metabolism study at University Hospital.
A clinical trial helped clear the way for the heart pump to be used in other patients.
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BROWNSTOWN TOWNSHIP -- Thomas Mator's doctors told him in 2001 they were out of options for treating congestive heart failure that threatened to end his life in months if not weeks.
Then a fluky connection changed his life. A college buddy of Mator's physician was heading up a clinical trial at the University of Michigan on mechanical pumps that keep failing hearts beating.
The doctor sent Mator to Ann Arbor, and within a few weeks surgeons were implanting one of the devices in his heart as part of the study. Today, the 71-year-old grandfather of 10 is alive and spending many of his days on the golf course.
"I think my game has even improved," Mator said, as a swishing sound emanated from the artificial pump attached to his stomach.
If not for the random link between two doctors, Mator could have died. His case illustrates why researchers are revamping the often haphazard way people find and participate in clinical studies.
Major research hospital such as the University of Michigan Health System are tapping into larger pools of federal money to fund more clinical trials and using the Internet to reach people across the country interested in participating.
U-M Health System -- which has 1,000 or so clinical studies taking place at any given time -- plans to announce today a Web site that will create a searchable database for the public to find trials that may apply to them. The site answers questions about trials and explains why they're important.
The federal government has a similar site that lists more than 22,000 National Institutes of Health trials. About 1,600 of the 7,000 people involved in trials conducted last year by the NIH Clinical Center found them through the Internet.
"That's a pretty powerful statement about how the important the Internet has been to helping us identify patients," said Dr. John I. Gallin, clinical center director.
Finding people who are willing to participate in trials is vital to researchers who are studying everything from determining whether a new drug is safe to discovering whether certain vegetables can improve health.
Human testing is a mandatory step in bringing any new drug or treatment to the market. Yet sometimes studies can stretch for months or years while researchers work to log enough participants. People shy away from testing, not willing to commit the time or fearful of negative health effects.
Research institutions have been conducting more clinical trials as the National Institutes of Health, the federal body that funds medical research, dishes out more money. NIH funding nearly doubled in the last five years, to $22.9 billion in 2004 from $12.9 billion in 1999.
"It's always been a bit of a problem to find individuals who want to be involved in research," said Dr. Dan Clauw, who heads the U-M Center for the Advancement of Clinical Research. "People have inaccurate perceptions, and all of us are getting busier. This is one way of making it simpler."
Researchers walk a fine line when it comes to enticing people to get involved in trials. They're allowed to pay people for participating, but only enough to compensate for their time, not to make money the main motivation for participating.
They must be clear about the downside and explain to patients that trials, while strictly safeguarded against harming patients, can produce side effects. Treatments offered in studies, while new, may be no better, or even less effective, than existing treatments.
But the promise of finding a new cure or helping to prove a theory can be appealing to patients. Clinical trials may offer new treatments when other options are exhausted and offer insight into medical conditions.
Some people, like Mator, see dramatic results. In addition to saving Mator's life, the trial helped clear the way for the heart pump to be used in other patients with congestive heart failure. Previously, the device was only for short-term use in patients awaiting a heart transplant.
While Sharon Sheldon's clinical trial experience wasn't life-changing, it may help the Ann Arbor woman improve her diet. She took part this year in a U-M study on the effect soy has on women who have gone through menopause. A vegetarian and soy eater, Sheldon was curious to know how much the food was helping her health.
For 12 weeks, she ate three slices of soy bread a day -- making sandwiches, French toast and sometimes even soy-bread croutons -- while doctors performed a battery of tests. She's awaiting final results, but already has learned that taking fiber with her soy will help her digest it more efficiently.
"I know the importance of testing out new methods and new strategies, so I wanted to do it," said Sheldon, who learned of the study because she sits on an advisory board that helps recruit people for trials.
At U-M, the Web site is part of a systemwide effort to increase participation in clinical trials. The university last year received a $3 million grant to meld clinical research and computer systems within the health system and a statewide network of community doctors
The Internet has been helpful in linking people with studies and getting the word out. However, NIH's Gallin worries that using the Web as a tool will exclude the poor and less educated, who aren't as likely to have Internet access.
"That's still a concern for us," he said. "How do you make it an equitable system?"
You can reach Sharon Terlep at (313) 223-4686 or sterlep@detnews.com.
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