A radium treatment given to hundreds of Maryland children from the 1940s to the 1960s and presumed harmless is being restudied by the Johns Hopkins School of Public Health and the National Cancer Institute to determine the cancer risk that might associated with it.
Pioneered at Hopkins 70 years ago, nasopharyngeal irradiation was prescribed to correct hearing, sinus and adenoid problems in children. The treatment involved inserting radium-tipped rods into the nose to shrink excess adenoid tissue that had caused the ailments.
The treatment also was given to about 5,000 submariners and more than twice as many airmen who suffered from ear conditions caused by water or air pressure.
But today former patients are questioning the possible long-term effects of the radium. Several brought their concerns to a federal panel reviewing human radiation testing during the Cold War. A former submariner who says he has nasopharyngeal cancer wants Congress to order a study of affected veterans.
Two past studies -- one in the Netherlands -- of people who received nasopharyngeal irradiation found the risk of cancer to be slight. But doctors said the study groups were small and the outcomes too statistically insignificant to link the radium treatment to the incidence of any subsequent cancers.
Researchers at Hopkins and the National Cancer Institute have decided to revisit the subjects because many are now at an age when cancers appear.
"This was an unusual type of exposure that has not been well-studied," said Dr. John D. Boice, chief of the radiation epidemiology branch at the cancer institute. "It was a very effective treatment. But there is this concern that radiation exposure carries a risk. Additional evaluation would be informative."
The outpatient treatment, preferred to surgery, took place in hospitals, public health clinics and doctor's offices. Radium-tipped rods were placed in each nostril for 12 minutes. Three or four applications were recommended over several weeks. The treatment fell out of fashion by the end of the 1960s as awareness of radiation dangers grew and alternatives became available to control ear infections.
The institute's follow-up will track 2,500 residents of the Netherlands who were treated as children and who were the subject of research published in 1989. That reported one case of brain cancer among those treated and two cases in a control group of people who were not treated.
The Hopkins study has begun following up 904 people who participated in a public health school-sponsored program to prevent deafness in children. They went to the Washington County Health Clinic between the 1940s and 1960s.
A 1982 Hopkins study of the group found that those who received radium treatments had a slightly increased risk of developing benign or malignant head and neck tumors compared with people who had been treated in another way.
Of the group who received radium treatments, three had developed brain tumors 15 to 20 years later; a fourth had cancer of the soft palate. In the control group, who did not receive irradiation, five developed breast cancer.
The Hopkins follow-up began last summer after national reports of human radiation experiments during the Cold War raised ethical and safety concerns. The publicity also provoked questions about medical techniques that were then acceptable.
Nasopharyngeal irradiation was among them. Hopkins issued a report last fall on the procedure, its development at the Baltimore medical institution and research about it.
"To date, there is still no definitely substantiated link between the applicator and cancer," the report said. "Research . . . has failed to uncover any irrefutable adverse effects."
But people who had been treated called with concerns. In the follow-up study, Hopkins researchers have sent health surveys to those treated in Western Maryland.
"We're doing it to find out if people should be concerned," said Dr. George W. Comstock, an author of the 1982 study. "In the late '70s, these people had not reached the age when cancer is more common. So we're hoping the numbers will be big enough to give us an answer."
But, he added, any discussion of nasopharyngeal irradiation must be conducted in the context of its time.
"What one should realize is radiation was the Cadillac of treatment in those days," said Dr. Comstock, 80, an epidemiologist who directs Hopkins' public health research center in Washington County.
No one knows for sure how many children or young adults received the treatment. After 1943, about 1,200 radium applicators were rented or sold to doctors. Ear, nose and throat specialists believe thousands of children were treated.
If such a widespread procedure had caused harm, large numbers of people would be complaining of health effects, said Dr. Donald F. Proctor, 82, the former Hopkins physician who designed the radium applicator in 1943.
"And there haven't been," he said. "I firmly believe there's no need to worry if they had this procedure."
Cherie Anderson and John J. McCarthy aren't convinced. The two Californians received the treatment as children. Each has suffered health problems they suspect arose from the radium doses they got.
Both have asked the presidential Advisory Committee on Human Radiation Experimentation to investigate.
"We don't feel there was enough data to support that this was a safe and effective practice," said Ms. Anderson, 50, founder of the Cameron Park, Calif.-based Survivors of Medical Radiation Experiments.
In Maryland, the Washington County Health Clinic in Hagerstown and the Baltimore public schools served as two study sites for the radium treatment. About 8,000 children were screened for participation in these Hopkins-sponsored hearing conservation programs.
The Baltimore study began in 1948. After 5,428 third-graders in 56 city schools were tested for hearing loss, 582 students were selected; half of the study group -- or 291 children -- received radium treatments.
Parental consent was obtained. The permission slips referred only to a "simple treatment," but newspaper reports of the study identified the treatment as "nasopharyngeal irradiation."
The five-year study, published in 1955, found that the treatment reduced the excess lymphoid tissue in the Eustachian tube and improved a child's hearing.
Joyce Malkinski and Frances M. Allen were among the Maryland children who received the radium treatments.
Mrs. Allen, 60, was a teen-ager when a screening at Southern High School indicated that she had hearing problems. She was told to report to the Municipal Building downtown for treatment. She recalls several visits.
"Back then, if the school told you to do something you did it. There was just no question at all," said Mrs. Allen. "What I would do is sit in a straight-backed chair with my head tilted back and sit there for 10 minutes with this thing that looked like a thermometer up my nose."
The Carroll County woman said she didn't think she had a hearing problem then and doesn't now. She said she feels fine and has had no health problems.
As a teen-ager, Mrs. Malkinski had chronic ear infections. She received the radium treatments from her doctor in the mid-1960s and the ear infections subsided.
She didn't think about the sessions in her doctor's office until 1986 when a malignant tumor was found in her Mrs. Malkinski's thyroid, the gland at the base of the neck that controls metabolism. The tumor was removed along with half her thyroid.
The 44-year-old nursery school teacher from Pasadena believes her cancer was related to the radium doses. She said her doctors told her the treatment "more than likely" contributed to her condition. She sees an oncologist annually.
In December, doctors found a tumor in her breast. It was benign.
Mrs. Malkinski said she is not bitter and believes her doctor acted in good faith.
"Nothing will change the fact that I will have to be on the lookout forever and ever," she said.
Dr. Comstock, of Hopkins, said the study now under way may be completed later this year.
He said anyone who received radium treatments should see a doctor if they now experience blockage or bleeding at the back of the nose or find a lump in the head or neck. They should say that they got radium treatments. "We admit there's a risk," said Dr. Comstock. "We don't know if it's little, big or so small we can't demonstrate. We're in an area where there's not nearly enough knowledge."