This is an archived article that was published on sltrib.com in 2006, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

An implantable heart pump now lengthens the lives of thousands of people too sick to qualify for heart transplants.

A new test informs women earlier in pregnancy whether their babies have Down syndrome.

And a popular dietary supplement doesn't relieve mild pain for people with osteoarthritis after all.

These are just a few of the recent medical advances achieved with the help of regular Utahns who give blood, take drugs, undergo surgery and otherwise offer up their bodies to clinical trials in the name of healthcare improvement.

Some do it for compensation. Some do it out of desperation. Some just want to contribute.

"It's the only way we can get new medications," said Deb Coleman, 53, of Murray. She's testing a potential cholesterol-lowering drug that she hopes will improve her family's track record of fatal strokes and heart attacks.

A culture of volunteerism, education and healthy lifestyles seems to draw a disproportionately high number of Utahns into clinical trials, said LDS Hospital cardiologist Jeffrey Anderson.

"They're interested in helping advance medical science," he said. "I've found this community to be very innovative by nature, as well as positive and forward-looking."

At least 500 clinical trials are currently recruiting in Utah. No one tracks statistics on whether Utahns participate at a greater rate than residents of other states, but researchers offer anecdotal evidence and applaud residents' willingness to step up.

"I've been other places, and a much more common response is, 'I don't want you experimenting on me,' " said J. Brent Muhlestein , director of cardiology research at LDS Hospital. "Here, they really see that this has the potential - even though it might not help them directly - to help society in general."

Even children participate at high rates, at least in cancer trials. Primary Children's Medical Center routinely enrolls more kids in cancer trials than most other hospitals in the Children's Oncology Group, an international network of 240 pediatric cancer-treatment centers.

Who's asking? You've seen and heard the advertisements: Do you have knee pain? High cholesterol? Crohn's disease? Does your teenager have delusions? Irrational thoughts?

The ads often are placed by local businesses recruiting patients for trials sponsored by the pharmaceutical industry.

Driven by demand for new drugs and therapies, research is no longer solely the domain of academia and research hospitals. In addition to high-profile institutions, such as the Huntsman Cancer Institute and the University of Utah School of Medicine, hospitals and clinics recruit and enroll patients in trials that may be funded by government, industry or charitable organizations, such as the American Heart Association.

Industry is funding a greater share of clinical research than ever before, according to a study published in the British Medical Journal in May.

John Ioannidis, a professor at both Tufts University in Boston and the University of Ioannina School of Medicine in Greece, analyzed the most frequently cited research from 1994 to 2003. He found government still funds most studies, but that industry's share has been steadily increasing.

Of the 487 Utah trials listed on Cancertrials.gov as recruiting as of mid-May, 292 are industry-sponsored, 162 are government funded and 173 come from academic or other sources. Some trials have mixed funding.

Registering on the government Web site is voluntary, so the actual number of trials is likely higher. The same is true of studies detailed on ClinicalTrials.gov, which lists trials by a range of sponsors on topics from childhood vaccinations to neurofibromatosis.

Developing a new drug that makes it to market can cost anywhere from $500 million to $2 billion, according to a recent report in the journal Health Affairs.

The increase in industry-sponsored studies has spawned a new field called community-based research. Pharmaceutical companies design studies and then hire private companies, sometimes across the country, to collect patient data on effectiveness, side effects and other factors.

A company managing a trial on an investigational meningitis vaccine, for example, might contract with a dozen pediatricians to recruit 6- to 12-week-old infants to get the vaccine.

Doing research in such familiar surroundings makes sense, said Werner Huck, president of Salt Lake City-based Advanced Clinical Research. ACR is currently enrolling patients in about a dozen studies in Utah and Idaho, including one on the cholesterol-lowering drug Coleman is testing.

"We feel many of the most promising therapies are best evaluated in the settings that they are going to be used in ultimately, and that is in the community," he said.

At Huntsman, researchers try to strike a balance between studies funded by national charitable organizations, industry and other sources, said Wallace Ackerly, who oversees clinical trial efforts for the institute.

"We don't want to stick our heads in the sand and not help the national effort," Ackerly said.

Weighing risks Participating in clinical trials can give patients early access to drugs before they reach market. In many cancer patients, when existing treatments stop working, clinical trial drugs offer new hope.

But the drug development system is not perfect. People endure side effects, and, though rare, some may die. Earlier this year, six healthy British men faced organ failure after volunteering to be the first humans to test a new immune stimulant in Great Britain.

To safeguard American patients against unreasonable risks, the U.S. Food and Drug Administration reviews applications for all potential human clinical treatments, whether publicly or privately funded. Trials move through three stages, going from a handful of patients used to explore safety to hundreds used for comparison with existing treatments.

Trials cleared for testing also are reviewed by Institutional Review Boards, independent panels that scrutinize trial proposals for scientific merit and ethical treatment.

Some drugs that reach the market may later be found to cause complications and serious side effects. Merck's pain drug Vioxx is among the most recent to be recalled due to suspected problems with placing patients at increased risk for heart attacks.

Wolfram Samlowski, a Huntsman expert on melanoma and kidney cancer who oversees more than 10 clinical trials, said he recently turned down one industry study because the proposed drug did not offer enough of an improvement over existing treatments.

Researchers monitor trial participants closely and remove them from the study if it appears their participation irreversibly jeopardizes their health, Muhlestein said. Even so, their participation is critical, he said.

"Patients have to be willing to participate in studies," he said. "Otherwise we'll never know the real answers."

The payoff In the cardiac realm alone, Utahns have helped researchers discover how low-dose beta blockers, inflammation and pumps affect damaged hearts. Those discoveries improved diagnosis and treatment for heart patients worldwide.

Anderson believes the most stunning advances are yet to come - possibly in the next 20 years - thanks to more than 12,000 patients, most from Utah, who have volunteered blood samples that will allow researchers to look for links between genes and heart disease.

Those links eventually could lead to personalized risk-and-treatment forecasts: If you have one specific genetic mutation, you are at greater risk for diseases A, B and C, and you're likely to respond to treatments G and H.

"We shouldn't expect immediate results," Anderson said. "But before long, a drop of blood will spit out our profile of what our risks are for heart disease and other diseases, as well as strategies of how we can prevent disease."

A few drugs can trace their earliest roots to this state. Prialt, a painkiller tested in Utah and elsewhere, owes its start to the lowly cone snail and University of Utah research.

"We were systematically checking everything in the venom of cone snails," said Baldomero "Toto" Olivera, whose U. laboratory found a compound that was eventually discovered to block severe pain in humans.

"We found this not because we were looking for a drug," he said, "but because we were doing basic research."

A colleague, then at the University of Southern California, helped move the find from the lab into a biotech company. Elan, an Irish drug company, eventually shepherded the drug through clinical trials.

Recent research led by U. professor of rheumatology Daniel Clegg offered new advice to the 20 million Americans suffering from knee pain related to knee osteoarthritis, the loss of cartilage that keeps the thigh and shin bones from grinding against each other.

Glucosamine and chondroitin sulfate, both substances found in cartilage, are marketed together as a "natural" pill for aching joints. While shedding extra pounds undoubtedly halts the condition, so few maintain weight loss that another solution is needed, Clegg said.

"You're left with pain management, really, because we don't have anything that seems to impact the disease," he said.

The nationwide study he led was the first large-scale, randomized trial to test whether the supplements ease pain as advertised. The answer, published this year in the New England Journal of Medicine, is no, at least for people with mild pain.

Some people with moderate to severe pain seemed to benefit from glucosamine, and Clegg is pursuing federal funding to research that further.

Salt Lake City resident Larry Seal participated in the trial. "I just figured if it was a benefit to me, great," he said, "and if it's a benefit to somebody else, it's that much better." rlynn@sltrib.com" Target="_BLANK">rlynn@sltrib.com glavine@sltrib.com" Target="_BLANK">glavine@sltrib.com

comments powered by Disqus