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The Paramus Post - Greater Paramus News and Lifestyle Webzine
Wednesday, November 14 2018 @ 07:16 AM EST
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The Paramus Post - Greater Paramus News and Lifestyle Webzine
Wednesday, November 14 2018 @ 07:16 AM EST
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The Paramus Post - Greater Paramus News and Lifestyle Webzine

Drug companies rely on volunteers to test their wares



CLINICAL TRIAL
Stevan Vela was watching an old episode of the television show "Bonanza" when he stumbled across his chance to become a human guinea pig.

An advertisement during a commercial break said that researchers at the University of California San Diego School of Medicine were seeking asthma suffers to participate in a clinical trial for an experimental medication.The appeal resonated with the 59-year-old retired teacher. He had suffered from chronic asthma most of his life, and in more recent years the wheezing, tightness in his chest and shortness of breath had worsened.

He had tried dozens of medications and treatments over the years. Sometimes they provided temporary relief, but none ever worked long term.

The commercial for the drug trial offered a new glimmer of hope, Vela said. "It sounded fascinating."

Every year thousands of Americans take part in studies that test the effectiveness and safety of medications and medical devices that haven't yet been cleared by federal drug regulators as accepted treatments.

The studies are a critical and potentially costly part of the process of discovering a new medical treatment and getting it to patients who can benefit from it.

Drug companies in 2006 spent an average of $930 million developing a prescription drug, according to Tufts University's Center for the Study of Drug Development in Boston.

Some of that money ends up in the pockets of patients and physicians who participate in clinical trials.

A doctor can receive several thousand dollars in compensation per patient for examining and monitoring as many as 24 trial participants over the course of several months, said Dr. David Frakes, global vice president for medical and scientific services for Quintiles Transnational, which manages clinical trials worldwide for drug manufacturers.

Patients get free medical care, medication and often cash compensation.

Vela said he received $1,200 for taking part in the UCSD asthma drug study, which lasted about 10 months and ended in October.

Payments to patients participating in research being conducted by UCSD's Alzheimer's Disease Research Center can range from $50 to more than $500, depending on the level of activity required by the study, said Dr. Adam Fleisher, the center's director.

"It's not meant as a payment for participation but for compensation for the time they spend," he said.

Other motives can come into play, said Dr. Gary S. Firestein, who directs UCSD's Clinical Investigation Institute.

"It turns out that many people enroll in clinical trials because they're trying to help other patients. They believe that even if it doesn't help them, it will help other people," he said.

Most trial participants are like Vela. They suffer from an ailment targeted by the drug being tested, and after trying approved treatments, they're ready for something else that might yield better results.

Clinical trials are often alluring because the new medications represent the latest that science and technology have to offer, but that doesn't assure success. Experimental drugs have unproven track records, and some never make it to market because they fail to pass the clinical trials test.

If you're thinking about participating in a trial, it's good to know how the test works.

Before a drug company begins a trial, it must seek approval from the federal Food and Drug Administration to conduct the study. Once a trial is under way, the activity is monitored by the FDA. Studies also are typically overseen by institutional review boards made up of scientists, doctors and others from local communities who monitor the risks posed to patients and make sure that the selection process for trial participants is fair.

Researchers are required to report any serious injury or reaction experienced by a patient to their review board within 24 hours, Fleisher said. Other adverse events must be reported on a monthly basis.

At any time, a review board or the FDA may shut down a trial for safety concerns. "These things are tightly regulated," Fleisher said.

Trials are conducted in one of four phases. Early phases involving smaller numbers of patients are designed to determine the treatment's safety and side effects. Later phases involve much larger numbers of patients and focus on determining the effectiveness of the drug or device and how it compares to approved treatments.

The trial operator must give every participant a consent form outlining the study's protocol, or process rules, and the patient's responsibilities, which can include periodic doctor visits, medical tests and procedures requiring hospitalization.

Following the rules is essential to the veracity of a study, Frakes said.

"You want a willing participant who fully understands the risks and benefits and is willing to commit to the time that it takes to do the study," he said. "You don't want someone who might forget to take half of the pills and at the end of the day you can't make sense of the data. We're looking for consistency across large numbers of patients."

Participants who become sicker during a study or suffer injuries related to the treatment are cared for immediately, Firestein said. Such problems are rare, he said, but when they occur, the sponsor of the study is generally responsible for the cost of additional medical care.

And at any time during a study, a patient can withdraw.

Vela, the retired high school English teacher, said he never considered quitting. He stuck with the trial even when researchers required him to undergo an uncomfortable procedure to remove bacteria from his lungs while fully conscious.

"That was the really hard part for me. It felt like they were beating me up from the inside," he said.

The effort appears to have been worthwhile. Vela said his asthma symptoms decreased dramatically during the trial and haven't returned to their previous levels since the study ended. The improvement means he doesn't have to spend $150 a month for many of the asthma medications he took before the trial.

"I feel better all-around," he said. "And my wife says I don't snore anymore."
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