Inhalers and Nebulizers

Researchers question safety of mist inhalers for delivering common drug for chronic lung disease

Inhalers and Nebulizers | Johns Hopkins Medicine

by Johns Hopkins Medical Institutions

People who use a mist inhaler to deliver a drug widely prescribed in more than 55 countries to treat chronic obstructive pulmonary disease (COPD) may be 52 percent more ly to die, new Johns Hopkins-led research suggests.

The findings, published by BMJ, the British Medical Journal, raise concerns not only about the mist inhaler — a device that delivers the soluble form of the medication tiotropium — but also about the drug itself. The mist inhaler has not yet gained regulatory approval in the United States, but the drug in its powdered form is commonly used to treat COPD here.

“What we think is going on is that the mist inhaler is delivering a higher concentration of tiotropium than it should be and that may be increasing the risk of death,” says Sonal Singh, M.D., M.P.H., an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine and the lead author of the study.

COPD, the fourth leading cause of death worldwide, includes the chronic lung diseases emphysema and bronchitis, which are usually due to decades of smoking. Tiotropium is routinely given to COPD patients with symptoms such as shortness of breath, and those with hospitalizations as a result of their breathing problems.

Singh says the increased deaths linked to the inhaler are primarily from cardiovascular disease. Anticholinergics, the class of drugs that includes tiotropium, increase the risk of heart rhythm disturbances (arrhythmias), especially among those with existing heart conditions.

In the United States and throughout the world, the medication is available in a powdered form and sold under the brand name Spiriva. Fifty-five countries now allow tiotropium to also be administered using the mist inhaler. Overseas, people with poor manual dexterity tend to be prescribed the mist inhaler because it is easier to use.

For the study, Singh and his colleagues from the United States and the United Kingdom reviewed and analyzed published findings comparing treatment with the mist inhaler containing tiotropium to treatment with a mist inhaler containing a placebo. They looked at five randomized, controlled trials, which included data on more than 6,500 participants.

Both the drug and the placebo were delivered with the Respimat Soft Mist Inhaler. The results show a 52 percent increased risk of death among those who used the mist inhaler with tiotropium, as compared to the mist inhaler with placebo.

Singh says his new research shows one excess death due to the mist inhaler for every 124 patients with chronic obstructive lung disease treated for one year.

What concerns Singh now is that there is a large, 17,000-patient, multicenter study underway in several countries, including the United States, comparing the two devices using the same drug.

“I'm worried about the participants assigned to the use of the mist inhaler,” he says. “They are not fully informed about what could be serious safety issues with the device.”

Singh emphasizes that while the current study only focused on tiotropium delivered through mist inhaler, the findings also raise serious questions about whether the drug tiotropium, in particular, and the class of inhaled anticholinergics, in general, are safe for COPD patients, particularly those with known heart problems.

The shortness of breath caused by COPD can be treated with other long-acting bronchodilators, such as the long-acting beta-agonists. The risk of additional hospitalizations for these chronic lung diseases can be reduced somewhat by other COPD inhalers.

At this point, Singh recommends that patients discuss the risks and benefits of COPD treatments with their doctors.

In New Zealand, a warning about a possible link between cardiovascular death and the mist inhaler has been included in the package insert for the device. In the United Kingdom, health officials advise caution in prescribing the mist inhaler to patients with arrhythmias.

Provided by Johns Hopkins Medical Institutions Citation: Researchers question safety of mist inhalers for delivering common drug for chronic lung disease (2011, June 15) retrieved 18 May 2020 from https://medicalxpress.com/news/2011-06-safety-mist-inhalers-common-drug.html This document is subject to copyright.

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Source: https://medicalxpress.com/news/2011-06-safety-mist-inhalers-common-drug.html

Large International Study of COPD Drug Finds Two Types of Inhalers Equally Safe and Effective

Inhalers and Nebulizers | Johns Hopkins Medicine

Newswise — An international study led by a Johns Hopkins pulmonary expert finds that the drug tiotropium (marketed as the Spiriva brand), can be delivered safely and effectively to people with chronic obstructive pulmonary disease (COPD) in both “mist” and traditional “dry powder” inhalers.

The new Respimat inhaler, which delivers the drug in a mist form, is approved for use in Europe but not in the United States. The traditional inhaler, known as a HandiHaler, uses a dry powder form of the drug and is widely used in the U.S.

The study comparing the two drug-delivery systems was a randomized, double-blind, prospective trial conducted at 1,200 sites in 50 countries with more than 17,000 COPD patients.

Results of the study are described in an article in the New England Journal of Medicine on Sept. 8, 2013, and are scheduled to be presented the same day at the European Respiratory Society meeting in Barcelona, Spain, by Robert Wise, M.D.

, professor of medicine at the Johns Hopkins University School of Medicine.

“This was a much-awaited study, because previous, smaller studies had raised the question of whether there was an increased risk of death with the newer tiotropium device, says Wise, who is the lead author of the study. “We needed a very large trial to answer the question.”

The researchers randomly assigned participants to one of three groups. Two different doses of the drug were studied among those who used the new Respimat inhaler.

“Our study found that the safety profile of tiotropium delivered with the Respimat system, in either a dose of 5 micrograms or 2.

5 micrograms, was similar to the traditional dose of the drug that is in wide use today delivered with the HandiHaler.

In other words, there was no significant difference in the incidence of major cardiovascular events or risk of death among the three groups studied,” Wise says.

Wise says the researchers also found that the risk of a first COPD exacerbation, defined as worsening of two or more major respiratory symptoms for at least three days, was no different when comparing the two devices or the different doses of the drug.

Tiotropium is a long-acting inhaled bronchodilator that improves lung function, quality of life and exercise endurance in patients with COPD. Patients were recruited for the study from May, 2010, through April, 2011, and followed for an average of 2.3 years.

The mean age of the participants was 65, and 71 percent of the patients were men. Patients in the three groups—those who used the dry powder and those who used either 5 or 2.5 micrograms of the mist—had similar COPD severity.

A substantial number of patients with a history of heart disease were included in all three arms of the study.

Death from any cause during the follow-up period occurred in 7.7 percent of patients in the lower-dose Respimat group, 7.4 percent of those in the higher-dose Respimat group and 7.7 percent among those patients using the HandiHaler.

COPD is a progressive lung disease that blocks air flow and makes it difficult to breathe. There are two forms of COPD—emphysema and chronic bronchitis.

According to the National Heart Lung and Blood Institute, COPD is the third leading cause of death in the U.S. and a major cause of disability.

It is often caused by smoking and also can result from long-term exposure to air pollution or chemical fumes.

There is no cure for COPD, but inhaled medications can delay exacerbations of the disease and improve quality of life.

The study was funded by Boehringer Ingelheim, the pharmaceutical company that makes tiotropium and the two different delivery systems.

Wise receives consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Mylan, Novartis,Pfizer, Sunovion, Pulmonx, Spiration, InterMune, Grifols and AstraZeneca.

He receives grant support from Boehringer Ingelheim, GlaxoSmithKline, Pearl Therapeutics and ForestLaboratories.

Other study authors include researchers from the University of Texas Health Science Center and South Texas Veterans Health Care system, Boehringer Ingelheim Pharmaceuticals, Odense University Hospital in Denmark, Service de Pneumologie Hospital Cochin, Assistance Publique-Hopitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, and Institute of Ageing and Chronic Disease, University of Liverpool, United Kingdom.

JOHNS HOPKINS MEDICINEJohns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is a $6.7 billion integrated global health enterprise and one of the leading health care systems in the United States.

JHM unites physicians and scientists of the Johns Hopkins University School of Medicine with the organizations, health professionals and facilities of The Johns Hopkins Hospital and Health System. JHM's mission is to improve the health of the community and the world by setting the standard of excellence in medical education, research and clinical care.

Diverse and inclusive, JHM educates medical students, scientists, health care professionals and the public; conducts biomedical research; and provides patient-centered medicine to prevent, diagnose and treat human illness.

JHM operates six academic and community hospitals, four suburban health care and surgery centers, more than 38 primary health care outpatient sites and other businesses that care for national and international patients and activities. The Johns Hopkins Hospital, opened in 1889, was ranked number one in the nation for 21 years by U.S. News & World Report.

Source: http://www.newswise.com/articles/large-international-study-of-copd-drug-finds-two-types-of-inhalers-equally-safe-and-effective

Two types of inhalers equally safe and effective, new study suggests

Inhalers and Nebulizers | Johns Hopkins Medicine

An international study led by a Johns Hopkins pulmonary expert finds that the drug tiotropium (marketed as the Spiriva brand), can be delivered safely and effectively to people with chronic obstructive pulmonary disease (COPD) in both “mist” and traditional “dry powder” inhalers.

The new Respimat inhaler, which delivers the drug in a mist form, is approved for use in Europe but not in the United States. The traditional inhaler, known as a HandiHaler, uses a dry powder form of the drug and is widely used in the U.S.

The study comparing the two drug-delivery systems was a randomized, double-blind, prospective trial conducted at 1,200 sites in 50 countries with more than 17,000 COPD patients.

Results of the study are described in an article in the New England Journal of Medicine on Sept. 8, 2013, and are scheduled to be presented the same day at the European Respiratory Society meeting in Barcelona, Spain, by Robert Wise, M.D.

, professor of medicine at the Johns Hopkins University School of Medicine.

“This was a much-awaited study, because previous, smaller studies had raised the question of whether there was an increased risk of death with the newer tiotropium device, says Wise, who is the lead author of the study. “We needed a very large trial to answer the question.”

The researchers randomly assigned participants to one of three groups. Two different doses of the drug were studied among those who used the new Respimat inhaler.

“Our study found that the safety profile of tiotropium delivered with the Respimat system, in either a dose of 5 micrograms or 2.

5 micrograms, was similar to the traditional dose of the drug that is in wide use today delivered with the HandiHaler.

In other words, there was no significant difference in the incidence of major cardiovascular events or risk of death among the three groups studied,” Wise says.

Wise says the researchers also found that the risk of a first COPD exacerbation, defined as worsening of two or more major respiratory symptoms for at least three days, was no different when comparing the two devices or the different doses of the drug.

Tiotropium is a long-acting inhaled bronchodilator that improves lung function, quality of life and exercise endurance in patients with COPD. Patients were recruited for the study from May, 2010, through April, 2011, and followed for an average of 2.3 years.

The mean age of the participants was 65, and 71 percent of the patients were men. Patients in the three groups — those who used the dry powder and those who used either 5 or 2.5 micrograms of the mist — had similar COPD severity.

A substantial number of patients with a history of heart disease were included in all three arms of the study.

Death from any cause during the follow-up period occurred in 7.7 percent of patients in the lower-dose Respimat group, 7.4 percent of those in the higher-dose Respimat group and 7.7 percent among those patients using the HandiHaler.

COPD is a progressive lung disease that blocks air flow and makes it difficult to breathe. There are two forms of COPD — emphysema and chronic bronchitis.

According to the National Heart Lung and Blood Institute, COPD is the third leading cause of death in the U.S. and a major cause of disability.

It is often caused by smoking and also can result from long-term exposure to air pollution or chemical fumes.

There is no cure for COPD, but inhaled medications can delay exacerbations of the disease and improve quality of life.

The study was funded by Boehringer Ingelheim, the pharmaceutical company that makes tiotropium and the two different delivery systems.

Wise receives consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Mylan, Novartis, Pfizer, Sunovion, Pulmonx, Spiration, InterMune, Grifols and AstraZeneca.

He receives grant support from Boehringer Ingelheim, GlaxoSmithKline, Pearl Therapeutics and Forest Laboratories.

Other study authors include researchers from the University of Texas Health Science Center and South Texas Veterans Health Care system, Boehringer Ingelheim Pharmaceuticals, Odense University Hospital in Denmark, Service de Pneumologie Hospital Cochin, Assistance Publique-Hopitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, and Institute of Ageing and Chronic Disease, University of Liverpool, United Kingdom.

Story Source:

Materials provided by Johns Hopkins Medicine. Note: Content may be edited for style and length.

Source: https://www.sciencedaily.com/releases/2013/09/130908135530.htm

FastForward U teams innovate with new and old technologies

Inhalers and Nebulizers | Johns Hopkins Medicine

This feature is a continuation of “FastForward U supports nascent student ventures “ on A1.

Bioswift 

In a city Baltimore where the prevalence of childhood asthma is more than twice the national average, Bioswift’s Flowmate aims to rectify a design shortcoming in dry powder inhalers. 

Dry powder inhalers are the latest standard in asthma treatment. It reduces the need for patients to press a button and inhale at the same time. However, it was designed with adults — who have larger lung capacities and overall stronger lungs than children — in mind. This means that child patients are often not receiving their full dosage. 

In an attempt to solve this, Bioswift created Flowmate as an attachment for dry powder inhalers for children. 

The Bioswift team is led by senior Maxwell Xu and includes seniors Varun Kedia and Isaree Pitaktong as well as sophomores Yunong Bai and Lily Zhu. 

Flowmate works by taking into account a child’s inspiratory flow rate and augmenting that rate to the threshold that dry powder inhalers have. 

“We’ve seen over and over again that this problem with dry powder inhalers is one that a lot of children have,” Zhu said. 

Currently the team is going through iterations of the product. They plan to complete validation and verification testing by the end of the semester. 

“We want to verify that it is not only a product that increases flow rate and [medicinal] depositions but also that it’s something that people can actually use,” Kedia said. “We want to make sure that it’s child-friendly and helps in a clinical setting.”

FastForward U (FFU) has helped the team with business development market analysis, researching alternative markets in order to scale their product and branding to develop the company. 

For Xu, one of the primary motivators to address a seemingly niche issue is not only its implications for medical treatment but also to raise awareness about the issue. According to him, the parents of many pediatric patients are unaware that dry powder inhalers do not administer the full dose in children. 

“We only know about this because expert pediatric pulmonologists presented us this issue to solve,” he said. “We want to help children know that they should not be using dry powder inhalers, or if they are, they should be using it properly.”

Cellular AnalysisTechnologies 

Un other Spark recipients which target problems in medical treatment, the focus of Cellular Analysis Technologies is an inefficiency in research lab technique. 

The team is developing a computer algorithm to automate the process of counting cells in a cell culture. The current, most widely used method involves looking at a culture through a microscope and clicking a device every time a cell is seen. 

When junior Christian Gonzalez encountered this inefficient process in his lab, he contacted junior Robert Waxman. Soon they created a nascent version of what is now Cellular Analysis Technologies. Sophomores Daniel Sun and Jacob Feitelberg along with junior Marc Bordui are also a part of the team. 

“We understand what it’s to count by hand and how monotonous and arduous it is,” Feitelberg said. “I don’t see why automation was not done beforehand.”

The team is using machine learning and artificial intelligence to simplify the process. 

With early support from The Hatchery as well as current mentorship and funding through FFU, the team said that they found creative freedom which they would not have otherwise had in a corporate or lab setting. 

Waxman also noted that the team has received significant funding from various other programs that Hopkins offers. 

“Although Hopkins did not have enough resources a few years ago, they have developed it, and I think that they are on a good upward trend in order to further develop the resources to support student start-ups,” he observed. 

Currently the team’s technology is optimized for breast cancer cells. They plan to have a minimum viable product by the end of the semester and eventually expand the technology to suit other cell morphologies by the end of the spring semester. 

“We hope to have a large-scale impact on cancer treatment,” Waxman said. “Our aim is to help increase the efficiency and accuracy of output for research labs. We hope that by increasing accuracy and speed we can help patients indirectly with their outcomes.”

PediaCORE 

The students behind PediaCORE have created a prototype to gamify physical therapy sessions for children with cerebral palsy. 

The team includes sophomores Joshua Park, Sundari Parise and Maggie Li, and seniors Akaash Sanyal, Nicholas Maritato, Tatiana Gelaf Romer and Teya Bergamaschi. The team is led by senior Samiksha Ramesh.

Ramesh explained that since children do not understand why physical therapy is a critical step in the healing process, they often do not have the motivation to complete the required repetitive motions. 

In an effort to make physical therapy sessions more engaging for the patients, the team has created a game- program which mimics physical therapy.

“We are trying to take aspects of virtual reality that make it beneficial in patient settings and are safe for children to use,” Maritato said. 

Amy Bastian, the chief science officer at Kennedy Krieger Institute, initially approached them with the project. Since then, the team spent the past summer refining their prototype.

In addition to working in the Bastian lab, Bergamaschi described how they had to complete various administrative tasks securing approval from the Institutional Review Board to conduct trials in the Hopkins Hospital.

“We spent this summer trying to get over all those hurdles except the business aspect of it,” Bergamaschi said. “That is where FFU came in and offered us the mentorship to make it a marketable idea.”

Weekly workshops touch on the various factors involved in transforming an idea into a company. They also attend one-on-one meetings every week with a staff member of the accelerator program who assists them to chart out and meet their business goals. This support has helped them to define their market and determine how to promote their product to potential consumers.

Multiple studies have found that cerebral palsy disproportionately affects low-income people. So a challenge for the team was finding a compromise between profitability and accessibility to those who need it the most. 

At first, in order to make it inexpensive, the team created an overly simple program. But after feedback and multiple iterations, they are closer to striking a balance. 

“Yes, we want to help people, and yes, we want to make it affordable, but at the same time we want to create meaningful technologies that people otherwise would not have access to,” Ramesh said.

Switchscopes

Similarly working on another innovation in the medical field, Waqas Haque and his business partners Ubaid Murad and Mohammad Badar are attempting to revive the art of the physical exam. Their product, Switchscopes, is a mobile medical imaging device which will serve as a supplement to a routine exam. 

Haque, a graduate student in the School of Public Health, and Murad and Badar, who are the CEO and vice president of Switchscopes, respectively, noticed a need for such a device when they were students in medical school and shadowing doctors. 

“When a mentor physician identified an important structure of the ear called the tympanic membrane through an otoscope, I had to grab the instrument at an awkward angle without losing place of the viewing field,” he recounted in an email to The News-Letter. “This is a common experience for budding clinicians learning the basics of the physical exam from another doctor.” 

Haque acknowledged that similar products are currently being developed by other companies. But he noted that the particular aim of Switchscopes is to make an affordable product to simplify teaching for medical educators and to accelerate diagnoses in underserved communities. 

The mobile-based device will use the built-in cameras along with additional lenses to examine body systems eyes, ears or skin. They believe that the ubiquity of smartphones will cheapen production and increase ease of use. For example, medical educators can store images to use later to teach students. 

the PediaCORE team, Haque mentioned how one of the main benefits of the FFU accelerator program is learning how to market Switchscopes. 

“We are currently participating in the Hopkins Accelerator program to further develop the business plan, to develop a landing page to attract customers and investors and to identify our best market,” he wrote. 

Currently the trio is developing their minimum viable product which they will test further after collecting feedback. They are also working toward securing intellectual property protection. 

Haque also noted the implications for doctor-patient interaction. According to him, a physical exam is almost ritualistic because it connects a doctor and patient. 

“Making the imaging of body systems reliable and portable will revive this dying art, where doctors can feel confident in their examination skills instead of solely relying on expensive imaging and lab tests,” he expressed.

Rudy Malcom contributed reporting. 

Source: https://www.jhunewsletter.com/article/2019/11/fastforward-u-teams-innovate-with-new-and-old-technologies

Asthma study patient worked at Hopkins lab

Inhalers and Nebulizers | Johns Hopkins Medicine

The woman who died after inhaling a drug in an experiment at the Johns Hopkins School of Medicine was a 24-year-old lab technician who worked for the university's asthma center, which conducted the study.

Ellen M. Roche of Reisterstown, whom friends described as a bubbly, vivacious person who loved horses and had just bought her first house, was to have been paid $365 at the completion of the experiment, according to interviews and documents.

“She was perfectly healthy and a wonderful person. It's just a tragedy to have something this happen. She volunteered for the study to try to help others,” said Charles Noel, a retired railroad supervisor from Reisterstown and longtime family friend.

Roche died June 2 at the Johns Hopkins Bayview Medical Center, about a month after taking part in an experiment designed to help doctors understand a healthy person's natural defenses against asthma.

She developed a cough and flu- symptoms a day after the test and was admitted to the hospital after X-rays showed a lung inflammation.

Roche's death was the first time in more than a decade that a research subject died at Hopkins from complications directly related to an experiment – not from an underlying illness.

The death was announced Wednesday by the medical school in a sparsely worded statement that did not identify the volunteer. The Office for Human Research Protections, which oversees the safety of federally funded research studies, launched an investigation the next day.

Yesterday, Hopkins released a detailed description of the study and a consent form shown to volunteers before they were accepted.

In the consent form, doctors warned of possible side effects including a cough, dizziness and a tight chest – but nothing life-threatening.

Medications and fluids would be given, they said, to reverse any side effects. A doctor would be present to treat the patient if problems arose.

Researchers planned to recruit 10 people, some of them staff at the Johns Hopkins Hospital and the Bayview Medical Center. While it is a common practice for medical centers to recruit employees and students as research subjects, some ethicists say it raises questions about whether they feel subtle pressure to volunteer.

In their description of the study, researchers said they were attempting to discover the natural mechanisms that protect healthy people from having asthma attacks. Asthma, which strikes 10 million Americans, is a disease in which the airways close down when patients breathe allergens, irritants or other substances.

The experiment, funded by the National Institutes of Health, was directed by Dr. Alkis Togias. It was part of a larger body of research overseen by Dr. Solbert Permutt.

In studies that began several years ago, Hopkins scientists discovered that healthy airways tend to close down, too. But people compensate by taking deep breaths that stretch the airways and cause them to reopen.

The experiment in which Roche died was designed to identify the exact reflex – the neurological pathway – that causes this response.

Volunteers were told that they would visit the center seven to nine times. During the first four visits, they would inhale a drug, methacholine, to induce “a mild asthma attack” that would produce a tight chest, some coughing and mild shortness of breath, according to the consent form.

“These go away on their own within a short period of time,” the form says. “If you do not want to wait until the symptoms go away on their own, a lung spray will be given to you which will take the symptoms away within a few minutes.”

Experts outside Hopkins said methacholine is commonly used in research and in clinical settings and is regarded as safe.

During the fifth visit, volunteers would be asked to take deep breaths before or after inhaling the drug, the form says. This would help doctors observe whether the breaths prevented the mild attack by opening the airways.

Roche apparently died in a subsequent phase of testing that began with the sixth visit. Some volunteers would take another drug – hexamethonium – before taking methacholine and breathing deeply.

Doctors had theorized that that drug would counteract the beneficial effects of deep breathing. If doctors could interfere with the body's defenses, they might better understand how those worked.

Hexamethonium could have side effects, the volunteers were warned. It could reduce blood pressure and make them feel dizzy when they stood up.

As a safeguard, volunteers would be hooked up to a heart monitor and have their blood pressure monitored. Doctors could also provide fluids through an intravenous tube if blood pressure sank dangerously low, the form said.

What sparked Roche's medical crisis remains a mystery. One question is whether the drug was to blame. Once widely given to treat high blood pressure and to reduce bleeding during surgery, hexamethonium has not been used clinically for many years.

A hypertension expert who was unfamiliar with the Hopkins case said the drug's benefits -and its side effects – were almost always short-lived.

“Whatever happened to the patient was probably unrelated,” said Dr. Edward D. Frolich, a hypertension expert at the Ochsner Institute in New Orleans.

In letters sent to federal oversight agencies, Hopkins indicated that it was analyzing the hexamethonium for possible contamination but was considering other causes, too. Scientists were studying a spirometer – a device that measures lung capacity – and other medical equipment as possible sources of infection.

Doctors performed an autopsy and were testing tissues to see whether Roche had developed an infection.

“There are no results at this time,” said Joann Rodgers, a Hopkins spokeswoman. “We are cooperating with these agencies and trying to find out [what happened]. That process is continuing.”

The safety of medical experiments has become a matter of public concern since the death two years ago of an 18-year-old man in a gene therapy trial at the University of Pennsylvania. That incident provoked calls for closer government monitoring of experiments ands better self-policing by medical centers.

Roche was one of seven children and stepchildren of a photographer, Bernard J. Roche Jr., and his wife, Carolyn, who have lived for years in a wood-frame home in Reisterstown that also serves as the photo business.

More than almost anything, Ellen Roche took great joy in caring for animals, friends said. She owned two horses, keeping one – called Clown – for a while in her family's back yard. She had enjoyed the Carroll County Rabbit Club and 4-H Club, according to an obituary in the Carroll County Times.

“She was a very nice girl, very outgoing, very helpful to others – and, boy, did she love her horses,” said Betty Noel, a longtime family friend.

Ellen Roche graduated from Franklin High School in 1994 and Frostburg State University in 1998. She worked in the labs at the Asthma and Allergy Center at Hopkins' Bayview Campus. And she was proud to have bought her own place last June – a $83,000 townhouse not far from her parents' Reisterstown home, friends said.

“She was such a healthy person – that's what really gets me,” said Betty Noel. “When I heard she was hospitalized, I just couldn't believe it.”

Hundreds of people packed her funeral June 7 at the Eckhardt Funeral Chapel on Reisterstown Road.

Craig Schoenfeld, an attorney who said he is acting as the Roche family's spokesman, said the family did not want to comment. “They are trying to grieve. When the time comes and they want to speak, they will speak,” Schoenfeld said. “But right now they are just trying to grieve.”

The Hopkins study was suspended after Roche became ill. She was the third volunteer to be tested, according to documents filed with federal agencies.

Hopkins employees say researchers often post fliers around the Bayview center cafeteria and elsewhere seeking recruits – fellow doctors, lab techs, students – for the center's experiments. That's because it's easier to find subjects on their East Baltimore campus than to find volunteers in the community.

Recruiting within an institution is common at academic medical centers, said Ruth Faden, director of the Hopkins bioethics institute. She said, however, that it is important to ensure that participation is voluntary.

“You certainly want to guard against a situation in which someone who is an underling feels manipulated or coerced,” Faden said. The practice at Hopkins is to post notices and advertise rather than directly ask employees to participate.

Outside Hopkins, ethicists were divided on whether academic medical centers should recruit employees for studies.

George Annas, chairman of the health law department at Boston University's School of Public Health, said he didn't see anything wrong with allowing an institution's employees to serve as research subjects – provided they feel free to refuse.

But Dr. Michael Grodin, director of medical ethics at that university's School of Medicine, disagreed. He said employees might be reluctant to say no, fearing they would not be seen as team players.

“The fact that it's convenient doesn't justify it,” Grodin said. “The bottom line is you shouldn't use people employed by the institution doing the research because there's potential conflict and coercion.”

Sun staff writer Michael Stroh contributed to this article.

Source: https://www.baltimoresun.com/news/bs-xpm-2001-06-16-0106160285-story.html