8th International Thyroid Cancer Survivors’ Conference
October 22, 2005
“But what assumptions are you making about fatalities from thyroid cancer?” I asked the senior Government official at the end of his presentation. He had just finished explaining, at a public meeting, why radiation-caused thyroid disease wasn’t worth preventing.
“No fatalities,” he replied. “It’s easily diagnosed and easily cured. No fatalities.”
The scene was the Nuclear Regulatory Commission, or NRC, in Washington, D.C., and the year was 1983. I was a lawyer working there, and as far as this official knew, I didn’t know squat about thyroid cancer, and he could tell me anything he liked.
The issue that day was whether the United States ought to stockpile supplies of potassium iodide, or KI -- the same chemical used to iodize salt -- in case of a nuclear accident that released radioactive iodine. It’s a very safe, very cheap drug, and it is very effective in preventing thyroid cancer, especially in children. After the Three Mile Island accident in 1979, the NRC had promised that it would require stockpiles of this drug around every nuclear plant. At the time, the pills cost about a dime apiece, with a shelf life of five years. It seemed like a no-brainer. But the nuclear industry -- that’s the companies that own the nuclear plants -- was dead set against potassium iodide, because it served to remind people that accidents can happen. And the industry had a lot of clout.
So in 1983, the NRC technical staff was proposing that the agency go back on its promise to stockpile the drug. They justified that reversal with a two-pronged argument. First, that nuclear accidents are unlikely, and second, that radiation-caused thyroid disease, if it does occur, is trivial. If your read the transcript of the meeting, you’ll find an NRC official explaining that even if the disease does occur, it just involves “a relatively minor operation” and “a few days loss.” They were careful to talk about “nodules,” never about cancer.
The gist of their argument was that even though potassium iodide was cheap, society would save money in the long run by not buying it. Then if there was an accident, we could take all the money we had saved by not buying the drug and use it to treat the cases of disease that resulted from not having it. Nobody mentioned that there might be some downsides to thyroid disease apart from the financial angle.
As it happened, I had had thyroid cancer 10 years earlier, when I was 26, caused by radiation treatments to my tonsils and adenoids when I was a 2-year-old. What these officials were saying didn’t sound like what I remembered my doctors telling me. I went to my office, phoned the American Cancer Society, and learned that it was then estimating 13,000 new cases of thyroid cancer every year and 1300 deaths.
That left two possibilities: either these NRC officials didn’t know the first thing about thyroid cancer, or for some reason they were bamboozling the public and the NRC Commissioners.
Thyroid cancer was the last thing I wanted to think about at that time. The disease was something in my distant past -- or so I imagined at the time -- but this kind of misinformation was hard to stomach. The NRC staff official refused to correct the record, so I went to the NRC Chairman and told him that he wasn’t getting accurate information about thyroid cancer. He arranged for me to have a meeting with experts from the NRC technical staff. At one point, one of them pulled a pack of cigarettes from his pocket. “Look,” he said, “for the price of this pack of cigarettes I can protect my whole family with potassium iodide. If I lived near a nuclear plant, I’d be crazy not to have it. But I think it would be obscene to make licensees pay for it.” (Licensees are nuclear power plant owners.)
Is that the kind of society we want, I wondered, where the children of the people in the know are protected, and everybody else’s kids are left in the lurch?
So events turned me into an activist of sorts of thyroid issues, and those events never seem to stop coming. Right now, there are two issues before the U.S. Government that involve the treatment and prevention of thyroid cancer, and that’s what I’d like to talk to you about today, with the hope, and the plea, that you will get involved.
One of those issues is, as I mentioned, potassium iodide for thyroid protection, which is a matter of preparing for acts of nuclear terrorism and major nuclear accidents. I’ll come back to it, but it’s not my first priority today. For there is a more pressing thyroid issue, one that probably affects or has affected most of us in this room, and that is the release of patients with iodine-131 in their systems. The question is whether patients who receive high doses of I-131 should be kept in radiological isolation, as they used to be, or treated as outpatients, as is often the case today.
For decades, there was a hard and fast rule, set forth in the NRC’s so-called “Patient Release Criteria.” If you received more than 30 millicuries of any radiopharmaceutical, you stayed in the hospital, in isolation, until the level of radioactivity in your body had dropped below that level. Once you were below the 30-millicurie line, you got sent home with the usual precautions about handling food, keeping safe distances, and all the rest.
In 1992, the NRC’s technical staff set out to change that hard and fast rule. The NRC announced that a petition had been received from a member of the public, asking for a rule change that would allow patients to be sent home with radiopharmaceuticals in excess of 30 millicuries in their bodies. (Just as an aside, this so-called petition from the public was actually a sham, because according to the person who submitted it, the NRC staff asked her to file it and dictated what it should say.)
Interestingly, the petition originally asked for the rules to be relaxed for all radiopharmaceuticals except I-131, though it was later amended to remove that exception. Because I-131 is different. This is the one radiopharmaceutical that actually has the potential to cause significant radiation exposure, and harm, to others.
The NRC staff, in a meeting with an NRC advisory committee on medical issues, proposed granting the so-called petition. The reason they offered was the psychological benefit to the patients. But when a member of the committee asked how thyroid patients actually felt at the time of treatment, the official making the presentation couldn’t answer the question. He didn’t have a clue.
Thus decisions affecting the lives of thyroid cancer patients and their families were being made by people who were willing to theorize about our psychological state as patients, but hadn’t bothered to inform themselves about our physical state.
The idea that the NRC was going to all this trouble just to make us cancer patients a little happier sounds positively heartwarming. Don’t bet on it. This was about money -- cutting costs for health care providers and insurance companies. Your and my psychological wellbeing was just a smokescreen.
The transcript of that advisory committee meeting shows that the chairman, a physician, was worried that the existing 30-millicurie standard might not be protective enough. He was concerned that people were going home with diagnostic doses of 5 and 10 millicuries of I-131 without adequate information about precautions.
The committee voted down the NRC staff recommendation. But that didn’t faze the NRC staff. Its mind was made up.
So the NRC published a notice in the Federal Register of the receipt of the petition and invited comments. A number of state health departments were very concerned, mostly because the special dangers of I-131 set it apart from other radiopharmaceuticals. Colorado and Alabama were opposed to any relaxation of the 30-millicurie rule for I-131. North Carolina pointed out that patients dosed with I-131 could cause significant radiation doses to “family members, coworkers and other persons they encounter.” The New York State Health Department had this to say: “At dosages greater than 150 millicuries [of I-131], nausea and the likelihood of vomiting are more likely and present a risk of extensive contamination.” New York was willing to consider outpatient treatment above 30 millicuries of I-131, but only to a maximum of 80 millicuries, and then only under special circumstances.
I also filed comments, as a private citizen, in which I pointed to nausea as a common side effect of I-131 treatment. I suggested that you could have people coming home and vomiting, and family members hastening to clean up the mess and getting a radiation dose in the process. Much as I disliked being in radiological isolation -- and I had five inpatient treatments when my cancer recurred in the late 1980’s -- there was a psychological benefit for me in knowing that in this way, I was minimizing the radiation exposure to my family.
How did the NRC technical staff deal with these comments from states and others? By ignoring them, and plowing ahead as though not a word of caution or criticism had been offered. A proposed rule was issued, with a public notice that said nothing about the states’ concerns, nothing about I-131 as a special case, and nothing about the danger of vomiting.
The proposed rule brought more comments, from myself and others, and in due course the NRC Commissioners approved a final rule, in 1997. The NRC’s final notice of rulemaking did deal, finally, with the objection that the rule change would mean larger doses of radiation to family members of thyroid cancer patients. And the NRC had an answer: yes, family members of patients will get more radiation, but members of the clergy who visit hospitals frequently will get less radiation, because the radioactive patients won’t be there, they’ll be at home.
It sounds like something off “The Daily Show,” but let me read you the paragraph:
The NRC agrees that, even though released patients are given instructions on how to limit the hazard from contamination, contamination control in a hospital can be more effective than contamination control out of the hospital. However, the two situations are not really comparable. In the case of the released patient at home, therapeutic administrations usually occur no more than once in a year and probably no more than once in a lifetime; but in the case of a hospital, large therapeutic administrations are done repeatedly on many patients. Therefore, areas in hospitals have the potential for contamination from many patients, and people who frequent the hospital (e.g. clergy or a hospital orderly) have the potential to be exposed to contamination from many patients.
What was wrong with the NRC’s reasoning, in the paragraph I just read you? Just about everything.
- The notion that I-131 treatment for thyroid cancer is probably a once-in-a-lifetime experience is an argument that some of us here might take issue with. How many here have had just one I-131 treatment? And how many have had multiple treatments?
- The argument that yes, family members get higher doses, but only once in a lifetime, implies that such a one-time exposure is a no-never-mind. But all our radiation standards start from the assumption that there is no threshold below which radiation is harmless. That keeps being reaffirmed, just this year in BEIR VII, which is the definitive word from the National Academy of Sciences on the biological effects of ionizing radiation. Statistically, more radiation exposure means more cancer -- maybe not to my kid or your kid, but to somebody’s kid.
- Members of the clergy are no more likely to get exposed to radiation from thyroid cancer patients being treated as inpatients than are pizza deliverymen, florists, ambulance drivers, or hospital employees generally. That’s the whole point of radiological isolation. A much more plausible way for a member of the clergy to receive a dose of radiation on a visit to a hospital is to ride in the same elevator as a patient who has just been given 150 millicuries of I-131 and told to go home. Thus even if viewed as a “Clergy Protection Rule,” this measure is a failure.
- Exposure of hospital orderlies to radiation (also mentioned by NRC) is a more legitimate issue. When I was an inpatient, a hospital orderly would enter the room once a day for a few seconds to collect the trash. But he was wearing protective clothing and a film badge. So were the women from Radiation Safety who came in each day to measure the radioactivity I was giving off. These were adults who had made a conscious decision to work in areas where they might be exposed to radiation. They had appropriate clothing, protective gear, and training, and their radiation exposure was monitored and limited. If you are given 150 millicuries of I-131 and sent home, no one provides your children with masks, gloves, booties, film badges, and protective clothing. You and they are on your own. And children’s thyroids are a lot more sensitive to the effects of radiation than adults.
I don’t think any Government agency could put out comparable misinformation on breast cancer, or prostate cancer, or lung cancer, for instance, without producing a storm of protest. There are too many people out there who know better. It’s only because we thyroid cancer patients are such a small and little-known fraction of the cancer population overall that people can write this sort of thing and get away with it. Maybe that will change, in the wake of Chief Justice Rehnquist’s illness and death.
I should clarify that it is not quite as simple as sending all patients home, regardless. The idea is that if the hospital performs a calculation, and concludes that no member of the public will receive more than a given amount of radiation from the patient, then the patient can be sent home, with a set of instructions. But realistically, if insurance companies are willing to pay for outpatient treatment but not inpatient treatment, hospitals will have an incentive to send as many patients home as they can, even in situations where there are children at home.
Where are we today? Already in 1999, I read on an internet radiation safety bulletin board about a thyroid cancer patient who vomited on a bus after receiving an I-131 treatment. Other passengers tracked through the mess before it could be cleaned up. I hear anecdotal reports today of patients coming home as outpatients and vomiting, and their spouses cleaning up. How often does this happen? I don’t know, and I’m not sure that there is any mechanism by which state or federal authorities would find out.
Here’s another data point: the National Institutes of Health, where they don’t have to worry about insurance company reimbursements, since treatment is paid for by the taxpayers, still follows the 30-millicurie rule. What does that tell you? I myself have more faith in the prudent, conservative judgment of the physicians at NIH than in the non-physicians of the NRC staff.
You may be asking yourself how other countries handle this issue. As it happens, there are International Basic Safety Standards, issued by the International Atomic Energy Agency in 1996, that address this very point. For discharge from the hospital of patients treated with I-131, they set a maximum activity level of 1100 Megabecquerels, which is to say, 30 millicuries. However, there is an asterisk and a footnote, which reads: “In some countries a level of 400 Megabecquerels is used as an example of good practice.” That is eleven millicuries. They really need to add a sentence to that footnote, and say: “But in just one country, patients are released from the hospital with activity levels of 5500 Megabecquerels or even more.”
Does it concern you that we have departed so far from internationally accepted standards of radiation protection? I have to say it concerns me.
I don’t mean to terrify everyone who ever had an outpatient treatment. We are talking about statistical increases in risk, not about large doses to family members (apart, perhaps, from the person who cleans up the vomit of a newly dosed patient). There was a study published in the Journal of the American Medical Association five years ago in which measurements were taken of the radiation emitted by I-131 patients and the doses received by family members. 65 patients were studied. The results were reassuring. But these were people wearing film badges, and perhaps more conscious of procedures for minimizing dose than the average family of the average patient. My impression -- and again, this is anecdotal -- is that there is a fair amount of variation from facility to facility in the kind of warnings that patients are given when they leave. [Is that others’ experience?] But the general point remains: the less extra radiation exposure the better, and children are more radiation-sensitive than adults.
Early last month, having heard one account too many of a patient coming home and vomiting up I-131, I filed a petition for rulemaking with the NRC that would restore the NRC’s old rules, as far as I-131 is concerned. If adopted, it would mean the end of outpatient treatments of more than 30 millicuries of I-131. It would mean less radiation to family members, and probably a smidgin more to orderlies. But the nation’s priests, ministers, rabbis, mullahs, shamans etc. can rest easy. They’re not going to get a bit more radiation.
I do not pretend to have a monopoly on wisdom on this issue. I ran the question by my hometown thyroid cancer support group last month. Most people said they would prefer to get their treatments as inpatients, but two disagreed: one who lived alone, and another whose family was able to move out for a week.
You may not agree with me on this. You may think that in-patient treatment is so unpleasant that the flexibility needs to be there to send people home. I think reasonable people can differ on this. And maybe there is a middle ground. But agree or disagree, I hope you will make your voices heard. Otherwise we will find that our medical care, and the safety of our loved ones, are being decided by people who either don’t know or are choosing to ignore basic facts about thyroid cancer and radiation protection.
The expertise on thyroid cancer that is gathered in this room today probably dwarfs the combined knowledge of the NRC, the Department of Health and Human Services, the Federal Emergency Management Agency, the Food and Drug Administration, and all the rest put together, but it isn’t being solicited. It isn’t wanted. On the contrary, the greater the expertise, the less they want to hear it. The NRC has repeatedly given the back of its hand to the American Thyroid Association, when it has offered the benefit of its knowledge of thyroid cancer issues.
At some point, the NRC will have to publish a notice of my petition for public comment. When that happens, I hope you will comment -- even if it’s to say I’m all wet. The NRC needs to hear what the thyroid patients themselves think, as well as the treating physicians and anyone else who is affected, including hospital personnel.
By the way, you’ll be interested to know that the South African novelist Nadine Gordimer, who won the Nobel Prize for Literature in 1991, has a new book coming out in December. It’s about a South African scientist who is being treated with radiation for thyroid cancer and somehow manages to irradiate his family, which causes havoc. My research indicates that South Africa has a 25-millicurie standard for releasing I-131 patients, so I’m not sure how this would happen. Maybe he got his treatment here. We’ll have to read the book and find out.
I’d like to end by talking, very briefly, about potassium iodide, or KI. In 2001, the NRC changed its rules and required states to consider the drug as part of emergency planning, and it offered stockpiles, free of charge, to any state requesting it, for a 10-mile radius around nuclear plants. This was in response to a petition for rulemaking that I had filed years before. But this wasn’t all my doing by any means. The American Thyroid Association played a huge role, as did a lot of activists in a lot of places.
This decision was made by the NRC Commissioners over the fierce objections of the NRC staff and the nuclear industry. The efforts to undercut it go on to this day.
Three years ago, Congress tried to broaden the availability of KI to a 20-mile radius. The National Academy of Sciences was to study the issues, and the Department of Health and Human Services was to draw up guidelines.
HHS issued draft guidelines on KI late last year. They seemed designed not to promote the wider use of KI but to bury it once and for all. It wasn’t until page 7 of the notice that cancer was mentioned. That’s exactly the same as putting out guidance on the Sabin vaccine and not mentioning polio until page 7. The particular susceptibility of children to radiation-caused thyroid cancer wasn’t mentioned at all.
The comments on this draft were brutal, and HHS wisely decided to rewrite it from scratch. A new set of guidelines was issued in August, and they are out for comment now. They are better than the last batch, but they are still unacceptable.
The issue is complicated, and rather than go further with it here, I’d like to refer you to the American Thyroid Association website. If you feel, as I feel, that the Federal Government has failed in its job of ensuring that this country’s children are protected against thyroid cancer, then I urge you to write your Members of Congress and Senators and tell them so.
For thyroid cancer isn’t trivial. It isn’t just “a few days loss.” So what if most of us here are going to die of something other than thyroid cancer? Diseases don’t have to kill you to have profound, life-altering effects.
The world has enough thyroid cancer patients already that we don’t need to create more through governmental irresponsibility. In the former Soviet Union, there are 4000 totally unnecessary cases of thyroid cancer today -- young people whose disease could have been prevented by the timely use of KI, as well as better control over milk and foodstuffs. With the knowledge that we have, and the resources that we have, there is no excuse for our country to be taking chances with our children’s health. We should have KI on hand to protect against acts of terrorism and nuclear accidents, and we should keep high-dose I-131 patients isolated until the greatest danger to children and others is past.
Last updated: October 23, 2006