Worse than the disease
To modern sensibilities, the procedure seems no less medieval than bloodletting. But for two decades after World War II, radiation applied deep inside the head was considered by many doctors to be the answer to chronic ear infections. Two long, wire-thin rods with radium tips were slid up the nostrils of the patient - typically, a child of 9 or 10, lying supine on an examining table - until they rested at the top of the eustachian tubes. The rods were left in place for eight to 12 minutes, and the radiation would shrink excess lymphoid tissue that blocked the airway and bred ear and sinus infections. The procedure was repeated three or four times, at two-week intervals, for a total radiation dosage equivalent to 10,000 dental X-rays.
But there was nothing scary about it, says Denise Peters of Abington, who had radium treatments in 1962, when she was 9 years old. Repeated ear infections had left Peters ``almost stone deaf,'' she says. Removing her tonsils and adenoids had done no good. Her grandmother took the girl to Dr. Robert Gilmore, a Quincy ear, nose, and throat specialist, who gave her nasal radiation. ``It was great for me,'' says Peters. ``It did help my hearing.''
A decade later, Peters began experiencing problems in her reproductive system. She battled benign tumors in her uterus, then cervical cancer. Peters, who is 45, has told her doctors about the radiation treatment she had as a child. ``Can this be the reason I'm the way I am?'' she has asked. Her doctors have no answer. Neither does anyone else. Nearly 30 years after the procedure faded from the medical scene, the lingering health effects of nasopharyngeal radium irradiation remain unclear. Although the treatment may have been performed on more than a million Americans, most of them children, research on its long-term consequences is meager. Some studies show an increased incidence of tumors of the head and neck - both malignant and benign - in those who received the treatment, as well as higher rates of thyroid disease. Evidence suggests that radiation damage to the pituitary gland may have caused hormonal imbalances resulting in reproductive problems as well.
But the research is by no means definitive. Nasal radium irradiation has been reviewed by a presidential commission on radiation experiments and by a workshop of experts convened by the federal Centers for Disease Control and Prevention in Atlanta. Both groups determined that the risks are so small and the exposure occurred so long ago that finding and notifying recipients would be a difficult and ultimately pointless exercise.
With recipients of this all-but-forgotten treatment scattered across the country and, in many cases, ignorant of the risks they may face, nasal irradiation could easily remain a curious footnote in medical history. But one man - Stewart Farber, a public-health scientist in Pawtucket, Rhode Island - is determined not to let that happen. For a decade, Farber has lobbied the nation's medical and political establishments to notify and examine nasal-radiation patients.
His doggedness - some might say obsessiveness - has paid off in Massachusetts, which last year became the first state in the nation to alert physicians to the risks associated with nasal radiation. The state Department of Public Health's advisory instructs doctors to perform ``thorough head and neck examinations'' on patients who say they've had the treatment and to report any apparent health effects to the state. It is the strongest step yet taken in response to nasal-radiation worries.
Neither the Massachusetts physician advisory nor any other official pronouncement has settled the question that has, on a national level, muddled the public-health response to nasopharyngeal radium irradiation: Does the long-abandoned treatment constitute a continuing health threat that merits public attention? But while the medical establishment and its critics wrestle with that question, behind it lurks another one: Does uncertainty have to mean silence?
In the 1940's, Dr. Samuel J. Crowe was a pioneering ear, nose, and throat specialist at Johns Hopkins University in Baltimore. Preventing childhood deafness, which often stemmed from chronic ear infections, was Crowe's passion. Radiation, he discovered, could reduce enlarged adenoids, which he thought made children more susceptible to ear infections, and prevent the tissue from growing back, as it often did after surgery. In 1944, Crowe and his associates developed an applicator containing 50 milligrams of radium 226, which has a radioactive half-life of 1,620 years, and put the device to work in a deafness-prevention clinic in western Maryland.
The new applicator also got a lot more use in the military in that last year of World War II. With Crowe's help, the Army Air Force opened clinics at air bases, including Westover Field in Chicopee, to treat flight-crew members who suffered inflammations of the middle ear caused by sudden changes in air pressure. The Navy sent Dr. Henry L. Haines, who was trained by Crowe, to the submarine school in New London, Connecticut, where he treated trainees who developed ear problems from pressure-chamber exercises and submarine-escape drills. After the war, pressurized cabins reduced the need for nasal radiation on aviators. But the Navy continued to administer the procedure to submarine trainees in New London, where Haines treated military and civilian patients into the 1960s. At least 8,000 US servicemen received the treatment during and after the war.
In the civilian population, the practice of nasal radiation took off. In 1948, The Saturday Evening Post called it a ``new treatment which eventually may prevent millions of cases of deafness.'' One practitioner complained in 1949 that ``the use of radium applicators in the nasopharynx has definitely reached the racket level,'' with some doctors applying the treatment ``for such alien conditions and symptoms as head colds, tinnitus [ringing in the ears], and chronic cough.'' But by 1970, the nasal-radiation fad had faded. The treatment was superseded by antibiotics and, in severe cases, drainage tubes surgically placed in the eardrum.
The treatment also lost favor because of a new, less sanguine attitude toward radiation. In the 1950s, nuclear-bomb tests were conducted in the open air; in shoe stores, children eagerly stuck their feet into X-ray machines to see their bones. Doctors used radiation not only for diagnostic purposes and for destroying cancer cells but also for treating acne and removing birthmarks. By the 1960s, the medical community had discovered the cancer-causing effects of some radiation exposures and curtailed radiation treatment in circumstances that were not life-threatening. But during the time that it was the treatment of choice for many ear, nose, and throat specialists, nasal radiation was performed on 500,000 to 2.5 million Americans, according to a Centers for Disease Control estimate.
Stewart Farber, who is 52, makes an unlikely Cassandra of radiation hazards. He has spent most of his working life in the nuclear power industry. A chemist with a master's degree in public health from the University of Massachusetts at Amherst, Farber designed environmental radiation monitoring programs for Yankee Atomic Electric Company, operator of the now-decommissioned nuclear power plant in Rowe, and worked at the utility's radiation-monitoring laboratory in Westborough. He spent two years as a radiological engineer and assistant manager of nuclear information for the New York Power Authority. In 1979, Farber moved to Rhode Island to help New England Electric System in its campaign, soon abandoned, to build a nuclear power plant. ``The environmental impacts of nuclear power plants are, by any honest evaluation, trivial,'' says Farber.
Though he is hardly a no-nukes alarmist, Farber was taken aback when, in 1981, he first heard of the nasal-radiation procedure. A friend of Farber's said he had had it done in 1965 by Dr. Henry Haines, who had put him at ease by telling him about the hundreds of submariners on whom he had performed the procedure. Troubled by the thought of radiation routinely applied just centimeters from the brain, Farber dived into the literature, then did some dose calculations based on the radium content and published treatment protocols. ``I was just astounded,'' says Farber. ``These were massive radiation doses compared to anything I was used to dealing with.''
At first, Farber found little interest in nasal radiation among medical professionals and researchers. But in 1989 he went to a talk by Dr. Alan Ducatman, a former Navy epidemiologist who was, at the time, director of environmental medical services at the Massachusetts Institute of Technology. Afterward, Farber approached Ducatman about nasal radiation.
``This guy came up to me after the lecture and told me this story that sounded unbelievable,'' remembers Ducatman, now chairman of community medicine at West Virginia University's medical school. Ducatman and Farber drafted a letter to the editor of The New England Journal of Medicine focusing on veterans who had been treated; it was published in 1992. ``Military personnel have a right to know of their exposure; they may be at increased risk of head and neck neoplasms,'' or tumors, they wrote. ``We encourage people who may have been exposed to identify themselves, and we suggest that formal programs for the identification and medical surveillance of such people are needed.'' The Navy responded by rejecting their suggestion, citing ``the patients' right to privacy'' and ``an almost complete lack of ... data.''
Then came the exposes of government-sponsored radiation experiments performed without the knowledge of the subjects, such as the ``science club'' at the Fernald State School in Waltham, in which retarded children were fed cereal and milk spiked with radioactive isotopes. These reports spurred then-secretary of energy Hazel O'Leary to open up government records of these abuses. ``I saw all this hoopla about, in many cases, trivial radiation doses,'' says Farber. ``I realized from the start that, given the number of people treated and the magnitude of the dose, nasal radium irradiation dwarfed every other experiment.''
Farber blanketed the offices of US Senators John Chafee, Republican of Rhode Island and former secretary of the Navy, and Joseph Lieberman of Connecticut, a ranking Democrat on the Armed Services Committee, with information on the veterans issue. His efforts prompted a 1994 Senate hearing. When Bill Clinton appointed the President's Advisory Committee on Human Radiation Experiments, Farber campaigned to get nasal radium on the agenda.
Farber also became, somewhat reluctantly, the hub of a diffuse network of nasal-radiation patients. He formed a group, the Radium Experiment Assessment Project, which he runs out of his Pawtucket home. He keeps a database - now more than 1,000 names - of people who have called him, usually following news reports, looking for information on the treatment they received years before. Some are simply concerned about what health risks they might face. Others, like Denise Peters, report medical problems that they, and Farber, suspect are related to nasal radiation.
Virginia Blatchley, 58, a psychologist who lives in Easton, Maryland, had nasal radium at Johns Hopkins Hospital for respiratory problems, at age 9. ``I remember it well,'' she says. ``It was uncomfortable, but not painful.'' Three years ago, she discovered a lesion on her tongue that turned out to be malignant. Blatchley was stunned. She used to smoke (``never more than half a pack a day,'' she says) but quit more than 20 years ago. ``Not one person in my family has died of cancer,'' she says.
As a child, Tom Clairmont, 49, of Belmont, New Hampshire, was treated with nasal radium at Laconia Hospital, for sinus infections. Three years ago, Clairmont discovered swollen lymph nodes on both sides of his neck, and a doctor's exam revealed a malignant tumor in his nasopharynx. Treating the rare cancer involved surgery, chemotherapy, and an extensive course of radiation - including treatments very similar to the ones he had as a child. ``Radiation caused it,'' he muses, ``and radiation took care of it.''
And then there's Dr. John W. Rhinehart, a psychiatrist and holistic physician in Newtown, Connecticut, who called Farber about his wife, Suzanne. She had been 15 years old, an active swimmer and diver living in New Rochelle, New York, when she had nasal-radiation treatment for chronic ear infections in 1947. In 1958, she was found to have an enlarged lymph node on the right side of her neck. It was Hodgkin's disease, a cancer of the lymphatic tissue. Suzanne Rhinehart died in 1964, at age 32. Was her cancer related to the radium therapy? ``There's no question in my mind,'' says John Rhinehart.
It's stories like these that kept Farber on the case nearly full time for the past three years, bringing him to the brink of bankruptcy. ``I've been touched by the human element,'' he says. ``I've heard these patterns of disease - all anecdotal, but they're there. This is an issue that deserves serious attention, and it's just not happening.''
But are these ``patterns of disease'' attributable to nasal radiation? Medical science offers no definitive answer.
The scientific literature on the effects of nasal radiation comes down to just two major studies. A 1980 Maryland study by a Johns Hopkins researcher found twice the rate of tumors - both malignant and benign - in treated subjects compared with those who did not receive nasal radiation. Treated subjects had a higher incidence of brain cancer, in particular, but there were too few cases for the difference to be statistically significant - that is, they could have occurred by chance. The researcher, Dr. Dale P. Sandler, also found an eightfold increase in thyroid disorders such as Graves' disease, which can cause rapid heartbeat, tremors, and anxiety.
However, a 1989 paper by a Dutch researcher, Dr. Peter G. Verduijn, found no increase in cancer deaths among people treated with nasal radium. Verduijn, who studied nearly 5,000 exposed and unexposed persons in the Netherlands, agreed with the Johns Hopkins study on one startling finding: Nasal-radiation patients had fewer cases of breast cancer than control subjects. A happy result, to be sure, but one that researchers say hints at a radiation effect on the pituitary gland, which governs the hormonal system.
The President's Advisory Committee on Human Radiation Experiments, extrapolating from the known effects of radiation doses, calculated that children who received nasal radiation faced a lifetime risk of brain cancer of 4.35 cases per thousand population, 62 percent higher than normal. The rate of all cancers of the head and neck caused by the treatment could be twice that high, according to the committee. This made nasal radium the only radiation exposure whose excess risk topped the committee's declared threshold of one case per thousand for triggering notification and follow-up. Nonetheless, the committee's 1995 report - which was widely criticized for reviewing thousands of radiation experiments and recommending substantive government action on none of them - advised against notifying patients.
One reason the committee gave was its conclusion that ``much of the risk has probably already been expressed'' - that is, anyone likely to have been adversely affected by nasal-radiation exposure has already been stricken. Also, the committee noted, there is ``neither an accepted nor recommended screening procedure'' for head and neck tumors; screening has not been shown to find such tumors early enough to make a difference in outcome. About radiation-caused illnesses other than cancer - including thyroid disease, which can mimic depression - the advisory committee was silent.
Still, the Centers for Disease Control and the Veterans Administration followed up the advisory committee report with a workshop on nasal radiation at the Yale University School of Public Health in September 1995. The Yale workshop also recommended against screening otherwise healthy individuals and called for more definitive data from follow-ups to the Sandler and Verduijn studies. But the CDC's report on the workshop, published in its Morbidity and Mortality Weekly Report, stated flatly: ``Current studies do not indicate substantial increases in risks for neoplastic [tumors] or other disease.'' The CDC did advise physicians to ask patients born before 1960 if they had had the treatment; if so, physicians ``may consider'' giving them ``thorough head and neck examinations.'' By dismissing the existence of any health threat, however, the CDC provided little rationale for doing so.
But the research, while limited, is not as contradictory as it seems. After the Yale workshop, Verduijn, the Dutch researcher, recalculated his data to reflect the incidence of cancer in nasal-radiation subjects, not just deaths from cancer. His revised paper, published with the other workshop proceedings in 1996, cites ``small but significant increases'' in cancer cases among the radiation-exposed subjects. ``The increased overall cancer rate in exposed subjects cannot be ignored,'' Verduijn concluded.
Verduijn's reversal has not altered the CDC's position that the risks from nasal radiation are not ``substantial.'' ``The studies do not indicate a large risk,'' says the CDC's Dr. Anne Mellinger-Birdsong. But, she adds, ``I would also agree that the [cancer rate] data can't be ignored and need further clarification.''
That clarification is coming slowly. Results from the updated Dutch study, which is being funded by the National Cancer Institute, are still two years off. Johns Hopkins will not release the results of its Maryland follow-up before they are published in a medical journal, which may not be for another six months. But the Johns Hopkins results can be found in the doctoral dissertation of the lead researcher, Hsin-Chieh Yeh, dated June 1997.
Yeh reports that four additional nonmalignant brain tumors appeared in radiation-treated subjects in her group after 1978, the cutoff date for the original study, for a total of seven in the population of 667. The risk of developing brain tumors, both malignant and benign, was 30 times greater for those exposed to nasal radiation; the risk of brain cancer was 15 times greater. In addition, a fourfold, but not statistically significant, increase in risk of thyroid cancer appears for the first time. ``This study alone cannot provide conclusive evidence of the causal relationship between [nasal] radiation and cancers,'' writes Yeh. ``Nevertheless, along with similar observations from other studies, such a conclusion is reasonable.''
Rear Admiral Harold M. Koenig, deputy surgeon general of the Navy, opened his testimony at the 1994 Senate subcommittee hearing on the effects of nasal-radiation treatment on a personal note. ``I, too, received this treatment as a child, for chronic tonsillitis,'' Koenig declared. ``Fortunately, all my examinations to this point have shown that I have suffered no adverse consequences.''
What examinations were those? asked Senator Lieberman of Connecticut, who was presiding.
Koenig said his doctors ``take extra care checking out my nasopharynx to make sure that there's nothing in there that shouldn't be there'' and closely examine the thyroid gland.
Lieberman turned to the other witnesses who had spoken: ``Am I correct in concluding that all of you agree'' that everyone treated with nasal radiation ought to get ``the kind of exam that Admiral Koenig has asked for himself?'' James M. Smith, representing the Centers for Disease Control and Prevention, demurred. ``I think one should be careful about sending out medical alerts without knowing with some confidence that there is a risk,'' Smith replied.
More definitive studies could, of course, settle this conundrum. Whether they will be done is another matter. The recipients of nasal radiation constitute neither a vocal, organized constituency nor a convenient population for study. Apart from Maryland and southeastern Connecticut, which were hotbeds of nasal radiation because of the aggressive practices of Johns Hopkins doctors and Dr. Henry Haines, former patients are spread randomly across the country. Treatment records, if they exist at all, are entombed in the archives of private practitioners long since retired, if not deceased.
If practical obstacles lie in the way of more systematic study of nasal radiation, so does the absence of an obvious villain. Lawsuits have a way of focusing scientific investigation, as in the case of silicone breast implants, and lawyers in Washington, D.C., and Philadelphia have signed up clients for a potential class-action suit on nasal radium. But just who could be held liable for nasal radiation is unclear: The government, for giving an experimental treatment to servicemen without informed consent? The manufacturer, for selling an unsafe product? The treatment's medical boosters at Johns Hopkins? After all, nasal radiation came and went during an era when the distinction between experiment and standard practice was more fluid than it is today. Nasal-radiation applicators were already gathering dust by the time the Food and Drug Administration gained regulatory authority over medical devices, in 1976.
Finally, although Stewart Farber can produce any number of individuals with health problems that can possibly be linked to nasal radiation, the medical profession has hardly been inundated with patients whose diseases can only be explained by this radiation exposure. ``I've never seen a patient with a tumor that could be traced to this treatment,'' says Dr. Sidney Kadish, a radiation oncologist at St. Vincent Hospital in Worcester. ``We just aren't seeing a harvest of disease.''
The state of Massachusetts would seem an unpromising place to overcome the scientific uncertainties and political vagaries of nasal radiation. Though home to perhaps 50,000 recipients of the treatment, the Bay State was not a center of nasal radiation, either in practice or in the subsequent controversy. But it was the Commonwealth of Massachusetts that, in a July 31, 1998, mailing, alerted its 27,000 physicians to the lingering, if disputed, dangers of the obscure treatment.
It helped that Farber had an ally in Dan Burnstein, president of the Brookline-based Center for Atomic Radiation Studies. The center is an advocacy group that had much to do with exposing the Fernald School experiments, and with which Farber's radium-experiment assessment is associated. At Burnstein's urging, the Governor's Advisory Committee on Radiation Protection, an appointed body on which Burnstein sits, heard a presentation by Farber in late 1995. Although the committee is dominated by radiation professionals who see little danger in most applications, the group agreed to take action on nasal radiation.
``These are real exposures to the brain and other structures of the head and neck,'' says state nuclear engineer Jim Muckerheide. ``I think [Farber's] right. The risks are real.''
Real, but small, panel members insist. ``In terms of the population as a whole, I don't believe any special action is warranted,'' says Dr. David Seldin, head of nuclear medicine at the Lahey Clinic in Burlington, who drafted the advisory. ``What we want to communicate to physicians, though, is that this is another source of radiation exposure they ought to know about.''
The state's more activist, though still cautious, stance put it at odds with the Centers for Disease Control. When the state advisory committee sent the CDC a draft of its recommendations - which stated that ``individuals exposed are at increased risk for developing cancer, particularly of the thyroid and brain,'' and urged physicians to ``have an elevated index of suspicion'' for such diseases in treated patients - the federal agency rejected the risk statement as ``incorrect.''
Shaken by the CDC's rebuff, the state advisory group sent to the Department of Public Health a draft physician alert that balanced, however awkwardly, the CDC's statement that ``current studies do not indicate substantial increases in risks'' with published data on excess lifetime risk of brain tumors. But the Massachusetts commissioner of public health, Dr. Howard Koh, in the first physician alert of his tenure - the DPH issues one or two such missives per year - toughened the advisory considerably. He removed the DPH's no-substantial-risk sentence, leaving the tumor calculations and the potential for thyroid disease to stand on their own. The only remaining qualification says that ``the risk of additional tumors is small.''
``Risk communication is a delicate art,'' says Koh. ``You don't want to panic people, but you also don't want them falsely, totally reassured that no risk exists. In public health, it's so hard to say yes or no.'' Koh also made the advice to physicians more admonitory, telling them that ``thorough head, neck, and thyroid examinations should be performed'' on patients who had nasal-radiation treatments. Finally, the advisory asks doctors who encounter patients whose symptoms ``might be related'' to nasal-radiation treatment to contact the Department of Public Health, thus creating the first reporting mechanism in the country for nasal radiation.
``Those are good recommendations,'' says Dr. Michael Grodin, professor of medical ethics at Boston University. ``First, you want to do the surveillance. Information is good.'' Once doctors become aware of the treatment, he says, they can work with their patients to devise appropriate examinations. ``The thyroid clearly could be examined. The nasopharynx can be examined,'' Grodin says. ``But patients can't make that choice if they don't know.''
If their doctors pay any attention to the public-health advisory, patients should know of the risks by the time of their next routine physical. Farber still thinks notification should go to individuals, not just doctors. He also quarrels with the assumption that the risk of tumors has somehow expired. But the Massachusetts action, he says, ``is certainly a step in the right direction.''
At least one recipient of nasal-radiation treatment agrees. ``I'm not looking to put the blame on anybody,'' says Denise Peters. ``I'm not someone to make a big stink. But physicians and people who had it done should know what to look for. Just let me know what I might be up against. Let me take care of myself first.''
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