Media Bias Toward Trials
This is my site Written by Alex on October 22, 2009 – 9:58 am   

A story headlined “Cutting-edge therapy is one reason why many participate in clinical trials” in the Indianapolis Star by Barb Berggoetz about why people enroll in clinical trials is indicative of an overall bias on behalf of the media toward encouraging participation in trials. Most stories about trials stress the positive outcomes. Some are so blatant as to almost seem like a public service announcement for the institution or business conducting the trial. The articles, like the one below, always mention risks. But, like I wrote in Chasing Medical Miracles about my own experience becoming aware of the real risks of any trial: “The trial up until now had been like taking a trip to Disney World. Before your plane takes off they tell you in detail what to do if it becomes a fireball of screaming death and dives nose first into the ground. But you don’t hear that part. You’re too busy thinking about shaking hands with Goofy.”

I realize it’s popular to bash the media but this is not a bashing statement. It is a warning to anyone enrolled or considering enrolling in a trial to read all articles about trials with a healthy skepticism and to always, always, always speak to outside sources (such as your physician) not affiliated with the trial about whether you should enroll. Being vigilant in learning as much as possible about the trial is ultimately the subject’s responsibility.

Cutting-edge therapy is one reason many participate in clinical trials

Clinical trials give participants cutting-edge therapy

By Barb Berggoetz
barb.berggoetz@indystar.com

The pay is usually little, just enough to cover expenses. You may be poked, prodded or at least undergo tests or medical procedures over a period of time.

Most often when you’re involved in a clinical trial for a new drug, you don’t know if you’re getting the real thing or a placebo. Risks exist, of course, even though medical professionals seek to lessen them.

So why do people in the Indianapolis area participate in the thousands of clinical trials going on in such facilities as the Indiana University School of Medicine, Eli Lilly and Co. and hospitals?

The answers are as varied as the people who participate in them: Access to cutting-edge procedures or drugs, usually free. Desire to help advance treatment of a certain disease or condition for others. Getting personalized care. And the hope that the treatment may improve your own condition or prevent offspring from getting it.

Renee White didn’t hesitate to sign up when her rheumatologist told her about a local trial. She suffers so much from fibromyalgia, a chronic pain condition causing tender points in joints, muscles and tendons, that she sometimes doesn’t want bed sheets touching her. Other times, walking on a concrete floor seems like a dull drill is shooting up from her feet.

“If somebody can find out by what I do, what can make it better for me and other women and men who suffer from it, I want to be a part of that,” said White, 52, Indianapolis, who was diagnosed in 2002.

She tries to avoid medication as much as possible. So she was attracted to a trial that tests the physical benefits of standing on a vibrating vertical platform when exercising. The ongoing trial is led by Anthony Kaleth, associate professor of physical education at Indiana University-Purdue University Indianapolis.

He is testing whether adding a low-frequency vibration emanating from the platform when doing exercises, such as squats and lunges, reduces pain and produces greater gains in muscle strength and balance than when exercising without the platform. Participants work out for 45 minutes, twice a week, for eight weeks in their homes with a trial assistant.

“This gave me the ability to get up and do more things, a little more, in my day,” said White. “It helps for a while, but I wonder if I strained a muscle on it.”

When participating in a trial, people don’t know exactly how the medication or treatment will affect them. But researchers say procedures and any adverse effects are strictly monitored by “institutional review boards,” and patients are told of all potential risks and fill out an informed consent form.

In so-called double-blind trials, participants don’t know if they’re getting the drug or a placebo. However, some research requires that patients at least receive the “standard care,” if a placebo would put them at risk.

“The risk is you may get a less effective treatment because you’re in the wrong group or a more invasive surgery because you’re in that group,” said Dr. Anatha Shekhar, director of the Indiana Clinical and Translational Science Institute at the IU School of Medicine. “The biggest risk is you may not get the best treatment.”

While he acknowledged that trials all involve a certain degree of risk, the least amount occurs in health outcome studies where everyone gets the right medicine, but some get more advice, exercise or other benefits.

Linda Rodgers, 56, diagnosed with early onset Alzheimer’s disease about three years ago, doesn’t know if she’s getting infusions every six weeks of a placebo or of an antibody designed to attack the toxic protein in the brain that builds up in Alzheimer’s disease.

Regardless, she and her husband and caregiver, Scott, agree it’s still worth it for her to participate in the 18-month trial led by Dr. Ann M. Hake, associate professor of clinical neurology at the IU School of Medicine.

Even if she doesn’t get the drug, she’ll get access to it after the trial and before it’s on the market, said Scott Rodgers.

“Alzheimer’s is a very unforgiving disease,” he said. “Nothing now slows down the progression. Most medications now just help with the symptoms. Anyone who has this really ought to take as aggressive an approach as they can in treatment and clinical trials.”

His wife — who takes memory tests, gets scans and answers questionnaires during the trial — said she isn’t worried about potential risks and doesn’t notice any side effects. But it’s too early to tell any positive results.

Coming in for regular visits and receiving close medical attention is one advantage of participating, said Hake.

“A lot of times we catch other things that are going on with them. We get things nipped in the bud if problems arise.”

Despite the potential benefits, finding enough patients isn’t always easy. Researchers say many people don’t know about trials and how they can benefit. Hake thought the Alzheimer’s study would fill up soon, but only eight people are enrolled after a year, and more are needed.

“It’s very hard to find patients,” said Shekhar. “The biggest thing we need to do is reduce the perception that these are high-risk, experimental therapies that people can get very hurt from. The majority of the time they are extremely well-controlled with a lot of safety and observations and don’t carry the risk people normally associate with them.”

The sheer numbers of trials going on adds to the difficulty.

The IU medical school and its teaching hospitals alone have about 2,000 trials per year with 10,000 to 15,000 patients, said Shekhar.

St. Vincent Hospital, which has an active clinical research program, has 650 trials now, many for new cancer therapies, said Robert Lubitz, vice president for research.

Nationally, most research studies don’t recruit enough patients, although it’s better locally, he said. The bottom line, researchers say, is the entire health system benefits when enough people are available to test drugs and procedures.

“The more patients you enroll in a study,” said Lubitz, “the more you learn about a disease and the treatment.”

Facts about clinical trials

What is a clinical trial? Biomedical or health-related research studies in human beings that follow a predefined protocol. Interventional studies test a treatment, drug or other intervention; observational studies observe participants.

Who can participate? Guidelines are based on factors such as age, gender, type and stage of disease, previous treatment and other medical conditions. Many studies seek people with illnesses or conditions being studied; others need healthy participants.

What is informed consent? The process of learning key facts, risks, potential benefits of trials before deciding whether to participate. People accepted in studies may withdraw at any time.

What are the risks? Unpleasant, serious or even life-threatening side effects may exist in experimental treatments. It may not be effective for a participant. A trial may require more of a person’s time and attention, such as trips to the study site, hospital stays (usually with higher payments) or complex dosage requirements, than other treatments.

What are the phases of clinical trials? Phase I: Researchers test an experimental drug/treatment on a small group (20-80) for the first time to evaluate safety and identify side effects. Phase II: Experimental drug/treatment given to larger group (100-300) to see if it’s effective and further evaluate safety. Phase III: Large groups of people (1,000-3,000) get drug/treatment to confirm effectiveness, monitor side effects, compare to commonly used treatments. Phase IV: Post-marketing studies outline more information, such as drug’s risks, benefits and optimal use.

Source: www.ClinicalTrials.gov, an online service of the U.S. National Institutes of Health

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