BANGOR, Maine — After Betsy Atwood suffered a heart attack in 2008, her local cardiologist asked if she would be interested in taking part in a study of a new drug that discourages the formation of blood clots.
“I thought I should probably help out the other ladies,” the feisty 67-year-old Prospect resident said. “Women with heart problems don’t always get all the attention they need. We get the short end of the stick, because we’re different from men.”
With some trepidation, Atwood agreed to join the national study, becoming one of hundreds of area residents engaged in the front lines of medical research.
In facilities ranging from small private practices to the largest clinical settings, patients from across northern Maine are enrolled in clinical trials of new pharmaceuticals, medical devices and other treatment innovations. Taking part in these studies benefits not only the patients, but also the clinicians and institutions conducting the trials and the health care world in general.
“Clinical research helps focus and channel the creative and intellectual energy of the medical community,” said Dr. Edward Harrow, a specialist in pulmonary medicine and chairman of the research advisory council at Eastern Maine Medical Center. “If we can imbue a questioning, academic atmosphere into the daily practice of medicine in Bangor, then we can provide the best care and attract the best physicians because this is a more exciting and stimulating place to work.”
The EMMC Clinical Research Center exists both to provide research training and support to area physicians and to attract national research dollars to the region. Since it was founded in 2006, about 2,000 patients have been enrolled in about 40 clinical trials of new drugs, new medical devices and new ways of using familiar drugs and devices.
“When I first came here [in 2006], the pharmaceutical companies didn’t even look north of Boston for study sites,” said research center director Dr. Barbara Sorondo. Now, she said, EMMC competes with larger medical centers throughout New England and the nation for recognition and vital research dollars to study conditions that are all too common in this area, including obesity, heart disease, lung disease, diabetes, cancer and neonatal abstinence syndrome. EMMC also has been a leader in implementing and researching telemedicine, the use of high-definition computer technology to bring clinical expertise to isolated rural areas.
Projects run through the EMMC Clinical Research Center since 2006 have brought in $2.3 million in public and private research funds, Sorondo said, supporting as many as 25 research jobs at EMMC and in the surrounding community.
“For researchers, the beauty of working in Bangor is that it is small enough to have a controlled environment, but large enough to provide a meaningful population sample,” Sorondo said.
EMMC is the largest clinical research site in the Bangor area, but a number of other regional medical practices also are engaged in testing new drugs and medical devices. All medications and devices studied here already have passed through several phases of the research process and are approved for use by the U.S. Food and Drug Administration. The studies being conducted in Bangor follow patients over extended periods of time, explore new combinations of therapy or in other ways look to clarify the safest and most effective way to care for patients.
In almost all cases, local research studies are tied to national trials. These trials are designed and funded by drug and device manufacturers in compliance with strict national research standards that protect patients’ medical welfare and legal rights and guard against clinical bias.
“It is important for people to realize that they are not guinea pigs,” Harrow said. “Clinical research is integral to the practice of good medicine.”
‘I was a little bit scared’
The study in which Atwood took part is examining the benefit of the new drug Vorapaxar when it is taken following a one-year course of the standard post-heart attack drug Plavix. Both medications are designed to make blood platelets less “sticky” so they won’t clump up, form clots and cause another heart attack. Nationwide, thousands of heart patients have participated in the study, which is funded by the manufacturer.
For 18 months, Atwood took the pills she was given — without knowing whether they contained the new drug or an inactive placebo. Her doctors didn’t know, either, and neither did the cadre of specialized health professionals who manage the research program at Northeast Cardiology Associates in Bangor.
This kind of “double-blind” study, in which neither the patient nor the researcher knows which patient is taking a test drug or a placebo, is the gold standard in clinical research, helping rule out the possibility that a researcher or patient may be biased toward one drug or the other. Only after the clinical data have been gathered and analyzed is it revealed what substance the participant has been taking.
“I was a little bit scared,” Atwood confessed. “But I knew I’d be getting extra medical attention, and I thought it would be kind of fun.”
Every three months for more than two years, Atwood made the drive to Bangor for a physical assessment, an EKG and some laboratory tests to see how she was responding to the mystery drug. She was paid a small stipend to offset her mileage and other expenses. Any time she had a question, problem or new symptom, she was given direct, same-day access to one of the Northeast Cardiology clinicians. Her health improved as she recovered from the heart attack. And then it was time to stop taking the pills, in accordance with the manufacturer’s directions and the study design.
Atwood said it will be another year or so before she finds out whether she was getting varaxopar or the placebo. In the meanwhile, she signed up for a new study to test a different drug, but stopped taking it after developing some related complications, including minor bleeding and bruising. She continues to be seen regularly in the research program at Northeast Cardiology; her adverse response to the new drug is an important part of the study.
Atwood is one of more than a thousand individuals who have participated in research through Northeast Cardiology Associates. According to Dr. Alan Wiseman, the practice has in recent years conducted studies on several different medications as well as devices such as pacemakers, internal defibrillators, and stents, the tiny tubes inserted into blocked blood vessels to prop them open. One study is looking at whether some people with blocked blood vessels are better off without the risky, intrusive procedure of stent placement, using certain medications instead to encourage better blood flow through the vessels. It’s not clear, Wiseman said, whether the more aggressive stent procedure actually prevents heart attacks or prolongs life. The outcome of the national study will be key to future clinical choices for doctors and patients, he said.
“A lot of people ask me why I do this,” Wiseman said. Though drug companies and device manufacturers pay medical practices to conduct clinical research on a local level, Wiseman said, Northeast Cardiology often breaks even or loses money in the trials, maintaining a dedicated staff of research nurses and other employees and complying with rigorous record-keeping and other requirements.
“It’s exciting,” Wiseman said. “It keeps us abreast of changes and new thinking. People doing clinical research are taking the time and trouble to to see what actually works and what doesn’t.” As clinicians, patients and insurance companies become more focused on the practice of data-driven, evidence-based medicine, he said, the information gathered at Northeast Cardiology and other Bangor-area research sites will help support “best practice” protocols for patients everywhere.
Tweaking out the right medicine
On the other side of the city, allergist Paul Shapero employs two full-time staff members just to manage his research patients.
“Our primary responsibility is to protect the interests of our patients,” Shapero said. Many of those patients suffer from respiratory conditions such as emphysema, asthma and chronic bronchitis and use multiple medications to control their symptoms.
“There are lots of people walking around who are still short of breath even though they take tons of medicine,” Shapero said. “They tell me, ‘I’ve been taking this [medication] for months or years and I still feel the same.’ The studies are aimed at tweaking out the right medication for the right patient. The patient is the ultimate judge.”
Patients who participate in drug trials typically feel empowered by the experience and are more likely to insist on effective medications and better care in the future, he said.
It’s too early to tell if that’s the case for 12-year-old Ian Day of Bangor, one of Shapero’s research patients. Diagnosed with asthma when he was 3 years old, Ian, a seventh-grader at James F. Doughty School, is accustomed to his body’s response to exertion, illness, weather and stress, all of which can trigger an asthma attack. He takes routine medications and carries an emergency inhaler. It all keeps him functioning at a pretty high level physically, he said.
“I know how my body reacts,” he said in a recent interview. “It’s not like I’m in constant worry or anything.”
But when Ian’s mother, Michelle Day, heard that Shapero was recruiting asthma patients for a double-blind medication study, she took her son in to see if he qualified for participation. He did.
“We went every two weeks for two months,” she said. But despite the new medication and a stepped-up level of medical care, Ian’s symptoms did not measurably improve.
“I think he got the placebo pill,” Michelle Day said.
But Michelle, who also suffers from asthma, was asked to participate in a different trial through Shapero’s office, testing an injectable medication. The improvement was quick and unmistakable, she said.
“I didn’t have to take any kind of allergy medication and I hardly ever had to use an inhaler,” she said. “When [the trial] stopped, all my symptoms came right back.”
One drawback to participating in trials is that the medications, devices or protocols being tested may be so new that insurance won’t cover them. Michelle Day’s coverage won’t pay for the pricey new drug she found so helpful, and the manufacturer doesn’t have a program to help consumers. She has returned to her former regimen, but hopes to work with Shapero’s office again.
“If you’ve been suffering with asthma as long as we have, anything is worth trying,” she said.
‘A wonderful opportunity’
Most clinical trials in the Bangor area are conducted out of physician practices, making it easier to line up appropriate participants. But since 2004, Acadia Clinical Research has operated out of offices on Hancock Street, trialing drugs for diabetes, high blood pressure, heart disease, influenza, bone disorders and other conditions. Local physicians oversee all studies conducted at Acadia.
Company founder Gail Baillargeon said Acadia always is looking for study participants; right now, she’s recruiting people with Type 2 diabetes to try a new insulin dosing regimen.
“The purpose of this study is to provide a protocol for family practice physicians,” Baillargeon said. “The benefit to the participants is that they get such close follow-up.” In addition to the stipend they are paid for participating and the intensive medical scrutiny they receive, participants get all their insulin and supplies for free for the duration of the study, she said.
“People need to know that participating in a clinical study is a wonderful opportunity,” Baillargeon said. “A lot of people are struggling financially and may be sacrificing their health and well-being. A clinical trial is a great way to learn more about your condition and available treatments, and to get the best care there is so you can improve your health.”
For Tom Christensen, the reasons to take part in a clinical trial are even more compelling. The 62-year-old University of Maine professor of engineering suffered a heart attack late last week and wound up with six stents. He said he was pleased to be asked to join a new national study testing whether two years of the anti-clotting drug Effient is more therapeutic than the standard one-year course.
As an engineering professional, Christensen said he has conducted research on numerous devices and innovations, including manufacturing materials and adaptive equipment for people with physical disabilities. Scientific studies are essential to developing effective new products and processes, he said Friday, during an interview in the hospital’s cardiac care unit.
“If we as a population don’t participate in studies like this, we’ll never advance medicine,” he said. “I’m here today because somebody else did this 10 or 15 years ago.”
There are risks and drawbacks to joining any clinical trial, including the possibility of receiving a placebo instead of the drug being tested. National standards require a detailed assessment to determine that a patient is appropriate for participation and a consent form that clearly and in “plain language” identifies all potential risks and benefits. Patients may withdraw from a clinical study at any point, and most studies make a point of involving participants’ primary care providers.
Maine residents interested in participating in clinical trials should consult their own physicians about available trials both here and in other states.