Elderly at Reseda Home Volunteer for Drug Study
RESEDA — Most old folks fear the flu. At 81, Martha Goldberg challenged it.
When doctors sought out residents at the Jewish Home for the Aging willing to become experimental subjects for a new flu drug, Goldberg was the first to sign up when the study began at the home in January.
“I’m gung-ho about this research,” she said. “I like to see progress and if we don’t try something, then we’d never get ahead.”
Doctors soon found that Goldberg wasn’t the only one willing to be a guinea pig. Sixty-nine other septua-, octo- and nonagenarians also signed up, ready to perhaps gamble their health on the power of an experimental drug.
Doctors say the population’s age extremes, the newborn and the elderly, are the most prone to serious harm, even death, from influenza because of weaker immune systems. That’s why researchers are testing zanamivir on nursing home residents across the United States and Europe. The Jewish Home for the Aging is the only California nursing home taking part.
If it works as researchers hope, zanamivir should both limit the symptoms of many common flu strains the test subjects may have, and also prevent them from spreading the virus to other people.
The thymus gland, the master gland for the immune system, deteriorates as people enter their 80s and 90s, making the elderly prone to infections, said Dr. Stefan Gravenstein, chief of the Glennan Center for Geriatrics and Gerontology at Eastern Virginia Medical School, and lead investigator of the drug trial.
“This is an ideal population to . . . study,” Gravenstein said.
The study is backed financially by Glaxo Wellcome, the drug giant based in Middlesex, England, that developed zanamivir.
Zanamivir is a powder. When inhaled, it settles on the mucous lining of the lungs. When the influenza virus attempts to insert its genetic material into the cells of a host, the drug, a neuraminidase inhibitor, blocks the neuraminidase protein the flu virus needs to grow and replicate, Gravenstein said.
The drug is different from others currently on the market because it is the first to attack the neuraminidase, Gravenstein said. Others, such as rimantadine, fight another protein called hemagglutinin,Q which the flu virus uses to attach itself to cells.
Unlike a vaccine, which is injected into muscle, the zanamivir acts directly on the lining of the lungs and can remain on the lung’s surface for several days, Gravenstein said. He emphasized that even if zanamivir is approved, those at risk, including the elderly, will still be advised to have annual flu shots.
Though results are preliminary, it appears flu viruses can’t build up as much resistance to zanamivir as they do to other drugs on the market or to vaccines, he said.
There’s no conclusion yet on how effective zanamivir is in preventing flu because the study on elderly patients is double blind, meaning that the doctors running it do not themselves know which patients receive zanamivir and which receive a placebo.
In a separate study last year, Dr. Frederick G. Hayden of the University of Virginia and his colleagues found that the medicine did not stop the illness but reduced its duration. According to a paper published in the Sept. 25 New England Journal of Medicine, the experimental medicine was tested on 262 adults who already had the flu in 70 medical centers in North America and Europe.
Hayden’s research was different because it dealt with treating the disease in non-elderly adults, but Gravenstein said that Hayden’s data indicate that the drug may work in preventing influenza as well as treating it.
In order to take part in the Jewish Home’s study, volunteers must first be exposed to the flu. But because this year’s outbreak is on the decline, doctors are now waiting for another round of flu to appear to administer the drug to healthy subjects to see if it protects them.
The flu season peaked some weeks ago. “We had a bad middle of December and first week of January,” said Dr. Shirley Fannin, director of disease control for Los Angeles County. But since then new cases of flu have slacked off, she said. “We’ll probably run into sporadic cases until March, but it’s quieted down a great deal since December.”
Indeed, some of the home’s residents said they may be too hardy to give the drug a workout.
Jule Leeds, 83, said the flu bugs wouldn’t dare touch her. “I’m too ornery, they know enough to stay away from me,” she said.
“I sort of sail through it,” said Charlotte Guyer, 90. “My kids say ‘Mom, you are a sturdy one.”’
The earlier outbreak did hit the home however, sickening about 50 of the 700 residents.
Goldberg was one of the unlucky ones. She said she caught the flu in late December right after her regular, nonexperimental flu shot. But instead of lying down, she spent most of her sick days sitting up in a chair and walked the home’s halls while everyone else ate their meals in the dining room.
“I’m not one for lying down,” she said. She is still waiting to take the experimental drug, which won’t happen until others around her come down with the disease and expose her to infection.
So far, only three of the 70 people participating in the Jewish Home’s study have taken the medication, said Julia Maglione, spokeswoman for the home.
Goldberg said she wanted to support the drug test because it is just such experiments that have created a world of advanced medicine from which she and other elderly people benefit.
“All this showed that they went ahead and experimented and it worked,” Goldberg said. “So many lives have been saved and helped.”
Residents say they don’t fear taking an unproven drug, that anything that will save people from the flu is worth trying.
“There’s so much we need to understand, so much we have to learn,” Guyer said. “We have to be aggressive to find out about all this.”
Zanamivir may be tested through one more flu season--October through March--before the data are analyzed, Gravenstein said.
If scientists can prove the drug works, they will request that the Food and Drug Administration approve it, a process that can take several years, said Julie Dean, spokeswoman for Glaxo Wellcome.
“It takes a long time to get a drug tested, an average of around 13 years to take a drug all the way to market,” Dean said. “Some are a lot faster than that. We’re hoping this one will be a little quicker.”
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Shielding From Flu
The experimental drug zanamivir is being tested on volunteers in homes for the elderly, including the Jewish Home for the Aging in Reseda, to determine if it protects them from coming down with the flu when others around them develop the disease. Subjects inhale a powdered form of the drug that coats the mucous lining of their lungs, to block the flu virus from replicating there.
* Replicative cycle of the influenza virus
The virus binds to the respiratory cell surface, then enters the cell. Once inside the cell, the virus reprograms the cell into replicating more of the vrus. After replication, the virus is released and finds other cells in the lungs to attack. An enzyme called neuraminidase, which is produced by the virus, is the key agent that allows it to be released from the respiratory cell.
* Introduction of zanamivir into the process
Zanamivir is a neuraminidase inhibitor and acts to block the neuraminidase enzyme. Researchers hope that without the enzyme, the virus will be unable to leave the cell and will die without spreading to other cells.
Sources: Dr. Michael Elliott of Glaxo Wellcome
