Residents near nuclear plants may get cancer prevention pills

By Rea Blakey and Elizabeth Cohen, CNN Medical Unit

ATLANTA (CNN) --More than two decades after the accident at the Three Mile Island nuclear reactor, the United States is again confronting the fear of an unexpected release of radiation. This time the concern isn't about an accident, but about a terrorist attack on a nuclear power plant.

The specter of such a strike has prompted the Nuclear Regulatory Commission to take a step many advocates have been demanding for years: supplying potassium iodide pills to people at risk of radiation exposure.

Potassium iodide, known as KI, is a cheap, nonprescription drug that is proven to prevent thyroid cancer -- one of the main causes of death after radiation exposure -- if administered within three to four hours of a nuclear release. But unlike many other countries, the United States has not stockpiled the drug as a precautionary measure.

"Why shouldn't America, and American children, have the same level of protection that kids do in France and Germany and Poland and Russia and Armenia and Ireland and Norway and a host of other countries?" asks Peter Crane, a former attorney with the NRC. Crane has been battling his former employer over the issue since the Three Mile Island accident.

Now, the NRC says it will offer KI pills to all 50 states. It will be up to each state to decide whether to take the pills and how to get the drug to its citizens, an NRC spokesman said.

Some states aren't waiting for federal help. Tennessee has already distributed KI to residents, and Alabama and Arizona are stockpiling the drug. New Hampshire is considering requiring pharmacies to carry KI so individual citizens can buy their own.

Mark Jacobs, who lives near New York's Indian Point nuclear power plant, carries a supply of potassium iodide for himself, his wife and his son wherever he goes.

"Every time I hear a plane going overhead I have to ask myself, 'Is that a plane that's going to continue or is it going to crash into Indian Point?' and that scares me," he said.

But not everyone is convinced KI is the answer. NRC chairman Richard Meserve says giving people KI could create a false sense of security.

"The more effective action would be to evacuate people, because KI does not provide complete protection," he said.

Another problem could be getting the drug to residents in time.

In the immediate aftermath of Three Mile Island, officials prepared 237,000 doses of potassium iodide, but the drug didn't make it to the scene for six days -- too late to do any good.

Ken Kelly, another Indian Point neighbor, says the solution is to move nuclear plants away from populated areas. But until such a step happens -- if it ever happens -- people like Mark Jacobs say they'll keep their potassium iodide pills handy.

http://www.cnn.com/2001/HEALTH/12/19/nuke.pills.nrc

Military Stocking Up on Anti-Radiation Pills
by Adam Entous, Reuters

WASHINGTON - (Reuters) - At the urging of the Bush administration, military commanders are quietly stocking up on anti-radiation pills and making plans to give them to U.S. troops should they be exposed to radioactive fallout from an attack or accident, according to documents and officials.

Suppliers of potassium iodide say shipments to the military have increased in recent months amid fears of war between nuclear-armed rivals India and Pakistan, and new terror threats against American targets including nuclear power plants.

One of the largest orders -- 134,400 potassium iodide tablets for 9,600 troops -- was shipped to the U.S. Army on May 28, according to records obtained by Reuters.

If taken immediately after exposure, the tablets have been shown to protect the thyroid gland from diseases caused by radiation.

A spokesman for U.S. Central Command said it was not distributing potassium iodide tablets to troops in Afghanistan and other South Asian countries, disputing the claims of several suppliers.

The Pentagon would not discuss its potassium iodide policy, which was outlined in an internal memorandum issued two months after the Sept. 11 attacks that killed more than 3,000 people.

In the memorandum, dated Nov. 19, 2001, William Winkenwerder, assistant secretary of defense for health affairs, directed Army, Navy and Air Force commanders to assess the risk to troops and to develop "implementation plans on the use of potassium iodide."

"The U.S. military overseas, their families, U.S. civilian workers and contractors may be at risk from hostile actions and other events against nuclear power plants resulting in radioactive iodine release," wrote Winkenwerder, Defense Secretary Donald Rumsfeld's chief health adviser.

In November and in a follow-up memo issued on Jan. 24, Winkenwerder told the services that they "must ensure availability of supply" of potassium iodide.

He also provided the secretaries of the Army, Navy and Air Force with guidance on how the tablets should be administered. It depends on whether the radioactive material is inhaled or ingested and on how long troops are exposed to a radioactive plume.

Winkenwerder put the Armed Forces Radiobiology Research Institute in charge of reviewing the plans. "We will take appropriate action when we get the plans," said Peter Esker, spokesman for the institute.

The Pentagon would not elaborate. "The policy memo speaks for itself," said James Turner, a Pentagon spokesman. "The commanders-in-chief, in any given part of the world, will assess the situation and will be responsible for providing appropriate material to their troops."

Underscoring U.S. fears that terrorists will try to use weapons of mass destruction, Winkenwerder announced on Friday a separate policy to vaccinate some military personnel against anthrax and to stockpile the vaccine for civilian use.

POTASSIUM IODIDE ORDERS RISE

Between January and June of this year, the military purchased more than 400,400 potassium iodide tablets -- enough for at least 28,600 troops -- through the Defense Logistics Agency and the Defense Supply Center in Philadelphia.

That amount represents an 80 percent increase over the amount of potassium iodide purchased by the military during the January to June period in 2001, according to Defense Supply Center records.

Potassium iodide orders surged after Winkenwerder's memo. In December and January alone, more than 303,000 tablets were purchased, enough for more than 21,700 troops. A 29,400-tablet order for 2,100 troops was filled by the Defense Supply Center on April 6, followed by the Army's 134,400-tablet shipment on May 28 for 9,600 soldiers.

The Defense Supply Center's figures do not include orders placed independently by the military services and their divisions, suppliers say.

The move to supply potassium iodide to troops and their families comes amid heightened fears that terrorists might attack nuclear power plants in the United States and abroad, or try to use nuclear or radiological weapons.

But potassium iodide's usefulness is limited since it must be taken almost immediately after exposure and only protects against absorption of radioactive iodine. The tablets offer no protection against other radioactive isotopes, which might be released by a "dirty" bomb and other radioactive weapons.

Despite these limitations, the military is not alone in stocking up on potassium iodide. The Department of Health and Human Services has purchased 1.6 million doses and plans to buy 5 million to 10 million more this year, officials said.

The Department of Veterans' Affairs has placed two large orders so far this year on behalf of HHS -- the first went to Salt Lake City in case of an attack on the Olympic Games.

The second order was placed within the last month for HHS' office of emergency preparedness, according to Veterans' Affairs. Officials would not disclose its destination.

Stored in secret warehouses, HHS' stockpile would be tapped in the event of a "catastrophe, man-made or otherwise, at a nuclear power plant," spokesman Bill Pierce said.

The Nuclear Regulatory Commission is also stocking up on the tablets as part of a program to make potassium iodide available to people living near nuclear power plants.

Food and Drug Administration Recommends Potassium Iodide
(source: FDA.gov)

 "The FDA has provided guidance previously on the use of KI as a thyroid blocking agent. In the Federal Register of December 15, 1978, FDA announced its conclusion that KI is a safe and effective means by which to block uptake of radioiodines by the thyroid gland in a radiation emergency under certain specified conditions of use. In the Federal Register of June 29, 1982, FDA announced final recommendations on the administration of KI to the general public in a radiation emergency." --

 http://www.fda.gov/cder/guidance/4825fnl.htm

Ireland: Anti-Radiation Pills For Everyone
by Brian Lavery

 "The government began sending potassium iodide tablets to households across the country for use in case Ireland is exposed to radioactive fallout from a terror attack or an accident at the British nuclear reprocessing plant at Sellafield, across the Irish Sea. The tablets prevent the thyroid gland from accumulating radioactive iodine, which was reported to have caused at least 2,000 cases of thyroid cancer after the Chernobyl nuclear disaster in 1986."

Back

Tiny Tablet, Big Possibilities  
by Ellis Henican

I am going to make your children safer today. In the event of an accident or a terror attack at a nuclear plant - say at Indian Point, 35 miles up the Hudson River from midtown Manhattan - this column just may save their lives.

Over the next few hundred words, I will convince you to stock the family medicine chest with something called potassium iodide. You will want to make sure the drug is readily available at school and day care too.

Think of potassium iodide as the little white tablet that, if we're all very lucky in this terror-prone era, no one will ever have to take. But I promise, this is one medication you'll want to have handy should the need arise.

I don't own stock in the company, a tiny operation run by two ex-New Yorkers. I met them just last week. But after three days of speaking with experts, asking tough questions and reading background reports, I am now convinced: In a big radiation leak, whether by accident or terrorism, this drug is still the best protection available against thyroid cancer, a key risk in a nuclear disaster, especially for kids.

But don't believe me. Believe Irwin Redlener, president of the Children's Health Fund and president of the Children's Hospital at Montefiore Medical Center. Redlener, who just may be America's leading advocate on child-health issues, is as gung-ho on potassium iodide as I am.

"We must be serious as we approach this new world of ours," Redlener was saying at week's end. "Potassium iodide is one of the few things we can do that will, without question, save lives if there is some kind of nuclear catastrophe."

Low-cost, easy to take, potentially hugely beneficial. "It should be in the medicine chest, right next to the ipecac," the poison-response medicine, Redlener said. "And not just in the area directly around a nuclear plant. We should think about a radius of 100 to 200 miles."

More of Redlener later. Some science, some history and some nuclear politics first. Potassium iodide works by saturating the thyroid with stable iodine. Then when the radioactive stuff tries to seep in, the saturated thyroid will not absorb it.

Sounds simple enough, but for a quarter century now, the Nuclear Regulatory Commission has been giving the cold shoulder to potassium iodide.

The World Health Organization, the U.S. Food and Drug Administration, the American Thyroid Association - they've all been calling potassium iodide a potential lifesaver in a nuclear accident.

But the NRC has had a ready answer for that: The chance of a accident at a nuclear plant was so remote, the federal regulators said, there wasn't any need for the pills. They'd only scare people. And if an accident did occur, a massive evacuation would be enough.

The 1979 accident at Three Mile Island did rattle some officials at the NRC, focusing attention on the drug. But only briefly. An emergency shipment was rushed by Air Force jet into Harrisburg, Pa. Local officials quickly realized, however, that the supply was nowhere near enough for everyone in harm's way. The pills were locked in a warehouse and never distributed.

The Chernobyl accident in 1986, the worst so far, raised the question of potassium iodide again. According to the United Nations International Thyroid Project, that accident had led to 11,000 cases of children's thyroid cancer by the year 2000, with thousands more expected in the next few years.

Interestingly, 97 percent of those cases occurred more than 30 miles from the plant, some as far as 200 miles away. Why not in the immediate vicinity? The Soviets distributed potassium iodide to the people in 19 close-in villages. The drug seemed to work.

It took Sept. 11 to really focus U.S. attention on the threat of a massive radiation leak at a nuclear plant. Now it wasn't just accidents the neighbors could worry about. There was also the genuine threat of a terror attack.

Before the end of last year, the Nuclear Regulatory Commission ordered 6 million potassium-iodide tablets and offered stockpiles to the 35 states with nuclear-power plants. New York State has requested 1.2 million pills, 500,000 of which are going to Westchester County, home of Indian Point.

The Centers for Disease Control purchased another 1.7 million tablets. A supply of potassium iodide was shipped to Utah for the Winter Olympics. The bulk, per-tablet rate? 17.8 cents.

These sales were progress, obviously. But the process raised as many questions as it answered. Who will get these pills?  Who might need them? And how should they be kept: in government warehouses, or distributed house by house?

No one is closer to the center of the swirling debate over potassium iodide than Alan Morris. He and partner Bruce Rodin are the founders of AnbexInc., a tiny drug company that is the federal government's sole supplier of potassium iodide and the only company with FDA approval to sell the drug to the public, under the brand name IOSAT. They have been focused on this drug since shortly after Three Mile Island. They've been trying to get it accepted - and widely sold - ever since.

"That 7.7 million tablets the government has already ordered, it's a start," said Morris, the company president and by far the more gregarious of the two. "But given the need out there, it is absurdly low."

Morris and Rodin sat in a midtown restaurant the other day and spoke about the raucous debate they're now in the middle of. "The pro-nuclear people hate us," said Morris. "They say, 'If we allow this to become widely known and used, people will say, ah-ha, nuclear power is dangerous. You see? You have this medicine.' They think it will erode public confidence in nuclear power."

Anti-nuclear people? "They hate it even more," Morris said. "IOSAT cuts the legs out of their basic argument. Their argument is that nuclear power is so dangerous, there's nothing you can do to protect yourself - other than shut down the plants at once. Well, we're talking about a medicine that will protect people from the danger of the plant. They don't want to hear that at all." But 9/11 has opened some eyes.

"Even if you believe a nuclear accident is impossible," Morris said, "no one can say these plants are protected against terror attacks, not when you find plans for nuclear plants in caves in Afghanistan. The U.S. is the only major nuclear power in the world with a major stockpile of this drug." And increasingly local citizens are demanding it.

That's happened in Westchester. The rumbles are spreading from there. Twenty-two million people live within 50 miles of Indian Point. How far will those 500,000 tablets go, when the FDA recommends one tablet a day for 14 days?

"Where are we going to move 22 million people and keep them for three weeks and not shut this country down?" Morris asked. "For 17.8 cents a tablet, we can avoid that."

And what about those people who live 50, 100, 150 miles away? That includes a big patch of the Northeast. And what about the other 103 nuclear plants in the United States?

Morris has a way of answering that. "The second-worst thing is not to have potassium iodide," he said. "The worst thing is not to have enough. If it's not enough, the half that doesn't have it will go crazy. Why not me? Am I the wrong color or the wrong ethnicity or the wrong sexual preference? They only gave it to the white people in Westchester. They didn't give any to us working-class people in Brooklyn and Queens. What are we gonna do? Are we gonna let our kids get cancer?" Ugly stuff.

Irwin Redlener, for one, is already thinking about all this. "If you look at a map of the nuclear plants and draw 200-mile circles around them, it basically covers the whole East Coast," he said. "We would recommend that every single family stock potassium iodide tablets. It is not good enough to be in a central repository. If you don't take them very shortly after exposure - within a couple of hours - they lose their efficacy. If it's more than six hours, it does nothing. Don't bother."

Obviously, some public education is needed between here and there. "There has to be a protocol that everyone understands and everyone signs onto," Redlener said. "It makes no sense not to do. This is one thing that will actually do some good."

http://www.buyiosat.com/press/newsday.htm

U.S. Lacks Stockpile of Anti-Radiation Doses
By Justin Gillis

U.S. lacks stockpile of special drug anti-radiation doses. The goal has been unmet since 1979. A generation ago, as a nuclear disaster unfolded in central Pennsylvania and 140,000 people fled the area, pharmaceutical executives were rousted from bed in the middle of the night by a plea for help.

At the federal government's request, they cranked up a production line in Illinois at 3 a.m., and hours later, thousands of bottles of potassium iodide, an anti-radiation drug, were secretly rushed to Harrisburg by military jet. Ultimately the nuclear reactor at Three Mile Island was brought under control and the drug was not needed, but it was a close call. When it was over, policymakers in Washington vowed to stockpile the drug, saying they would not be caught short again. It never happened.

Terrorists have spoken longingly of their desire to blow up the United States' nuclear plants and poison the land with radiation. But if a nuclear disaster were to occur today, whether by terrorist strike or otherwise, the government might well be in the same position it was in1979, trying to scare up supplies of the drug on short notice.

Potassium iodide is often billed on the Internet as a panacea for a nuclear emergency. It is nothing of the sort, offering no protection for most types of radiation exposure. But there is strong scientific evidence that it can protect the thyroid gland, the most radiation-sensitive part of the body, from absorbing trace amounts of radioactive iodine, particularly in young children.

Despite that finding, there has long been a serious debate about how valuable stockpiles of the drug would be in a real-world emergency, since it is most effective when taken within a couple of hours of radiation exposure. Unless people already had it in their houses, skeptics argue, getting it to them that quickly would be difficult, at best. Most European countries and four U.S. states stockpile the drug for general public use, while the rest of the states and the federal government do not.

That policy is under renewed scrutiny since the Sept. 11 attacks and the anthrax scare that followed. The federal government was better prepared for the anthrax emergency, in fact, than it would be to distribute potassium iodide for radiation. It had stockpiled millions of doses of antibiotics and was able to draw on those stores when thousands of exposed people needed preventive medicine. The lack of a potassium iodide stockpile irks many doctors and other experts who have delved into the issue.

"The first thing is, there are none available," said David Becker, a Cornell University specialist in thyroid diseases. "Some of us in organizations like the American Thyroid Association have been yelling and screaming for 15 years about this. It seems to me it doesn't make any sense for the U.S. not to have any at all."

Potassium iodide is not expensive, nor is it difficult to manufacture or store for long periods. The drug is approved for thyroid protection by the Food and Drug Administration, a position the agency reiterated earlier this month.

One reason for the lack of a stockpile is that, however cheap it may be, potassium iodide is also controversial. The nuclear power industry, which stocks potassium iodide to protect workers in its plants, has long opposed a large public stockpile, carrying as it would the implication that nuclear power might be unsafe.

Some experts charged with protecting the public from radiation oppose it, too, fearing the drug would be seen as a cure-all. These experts contend that evacuation and careful monitoring of the food supply would be better ways to protect public health.

In the halls of Congress and elsewhere in the nation, these arguments are being scrutinized anew. The Nuclear Regulatory Commission, after going back and forth for years, has adopted a policy that is mildly favorable toward potassium iodide. The Health and Human Services Department is considering whether to add the drug to its national anti-terrorism stockpile.

Under the new NRC policy, states must decide whether to tap NRC funds to create regional or local stockpiles. This means a public discussion of the drug and its potential usefulness is likely to occur in virtually every state over the next year.

The drug is a hot political issue in some communities. Alabama, Arizona, Maine and Tennessee already have some form of stockpiling. The citizens of Duxbury, Mass., who live near a nuclear plant, passed a stockpiling plan last year. Vermont recently pledged an expanded stockpile, and a vigorous debate is underway throughout New England and in some towns in New York.

The World Health Organization recommends stockpiling for every country with nuclear reactors operating within or near its borders. Ireland just announced plans to send the drug to every household in the country.

Potassium iodide availability is one of those issues that rarely rises to public awareness, but it has a long underground history that has played out in Washington and in state capitals over decades. The arguments being heard today are familiar ones to participants in that debate, with fear of terrorism as the new twist.

"In the immortal words of Yogi Berra, it's d?j? vuall over again," said Jerome Halperin, the man who rousted pharmaceutical executives from bed during the Three Mile Island crisis. He was then an officer of the FDA, and he has a hard time believing the nation has no stockpile 22 years after the federal government promised to build one.

"It's the appropriate, rational, public-health-preparedness thing to do," he said. "Why wouldn't we expect it?"

But others are skeptical of the value of stockpiling. Illinois, for instance, has 11 nuclear reactors operating on six sites, more than any other state, and it has made some of the most elaborate plans in the nation for responding to a radiation emergency. They call for people to evacuate or take shelter when necessary to escape a radiation plume, but they do not call for potassium iodide. Most other states that have considered the issue have adopted the same position.

The Nuclear Energy Institute, a trade association for the nuclear industry that has long opposed stockpiling, says it can live with the new NRC policy, but its experts remain skeptical of the real-world value of potassium iodide. "Concern No. 1 is that people not get confused that this is some sort of panacea for any kind of radiation exposure," said Ralph Andersen, chief health physicist at the nuclear institute.

The value -- and the limitations -- of potassium iodide have been known to researchers for decades, and there is little dispute on the scientific points.

Nuclear reactors produce many radioactive substances that can harm people. One, radioactive iodine, poses a particular worry because the human thyroid gland uses iodine as a fundamental building block of hormones that play critical roles in metabolism. The body cannot distinguish the safe form of iodine present in food and table salt from the radioactive form that comes from nuclear reactors.

It has been known since the 1950s that young children are acutely sensitive to radioactive iodine, but the point was illustrated dramatically when the Chernobyl nuclear plant in Ukraine blew up in 1986, scattering radiation across hundreds of miles.

For those living at a distance from the plant, virtually the only known health effect has been a huge spike in cases of thyroid cancer among children. At least 2,000 "excess" cases in Ukraine, Belarus and nearby areas have been attributed to Chernobyl radiation. Thyroid cancer can usually be treated, but that may require surgery, regular monitoring and lifetime medication.

The idea behind potassium iodide is that the thyroid gland can store only so much iodine. A potassium iodide pill given near the time of radiation exposure floods the gland with safe iodine and reduces or eliminates the absorption of radioactive iodine. Potassium iodide is the same chemical used to add iodine to table salt, but the pills contain higher doses. Anyone can buy the pills, though they are not widely available in stores and most people do not know about them.

Potassium iodide can protect people only from radioactive iodine, not other kinds of radioactive fallout. Bearing that in mind, skeptics say the much-preferred course, in an accident, would be to get people out of the radioactive plume or into shelters. Advocates of the drug tend to agree, they but argue that if evacuation plans went awry, potassium iodide would be better than nothing.

Whatever the merits of these positions, there is no doubt that during Three Mile Island, the nation's closest brush with nuclear disaster, the government wound up scrambling to round up supplies of the drug at the last minute.

In that episode, a partial "meltdown" at a nuclear plant led to the release of small amounts of radioactive material, including iodine. For several days there was fear the reactor would explode, and state evacuation plans turned out to be woefully inadequate. Given the prospect of widespread radiation exposure, the FDA decided midway through the disaster to rush a supply of potassium iodide to Pennsylvania.

Hunkered down at an FDA emergency center, Halperin and colleagues spent the evening of March 30, 1979, desperately calling pharmaceutical and chemical companies. Finally Mallinckrodt Inc. of St. Louis said it had bulk drug on hand and could package it at a plant in Illinois. The first bottles were flown to Harrisburg the next evening by Air Force jet.

To forestall a riot, no public announcement was made about the drug. The emergency passed without it being used, and eventually the stockpile grew old and was discarded.

A presidential commission that investigated the accident, appalled by this frantic episode, recommended broad stockpiling of the drug in the areas around nuclear reactors, and the NRC agreed. But as memories of the emergency faded, the agency backed out of that commitment, and the issue has been periodically debated ever since.

Many opponents of stockpiling acknowledge that Chernobyl provides compelling evidence of the risk of thyroid cancer from a radiation disaster, but they say a comparable degree of exposure would be unlikely in this country.

When Chernobyl blew up, the Soviet Union spent days lying about the accident and failed to halt distribution of contaminated food. There is evidence that much of the radioactive exposure came from this failure. The radioactive iodine fell on fields, cows ate the grass, and children drank milk from the cows. Safety experts say the United States, by contrast, would almost certainly move quickly to block radioactive food.

The most recent federal policy change on potassium iodide came before the terrorist attacks of Sept. 11, but the issue has taken on a new urgency since those attacks.

The change was initiated from within the NRC itself. Peter Crane, then a lawyer on the agency's staff, was a thyroid-cancer victim who thought the failure to stockpile could not be defended. He filed a petition as a member of the public in 1995, then spent years prodding the agency. It eventually adopted a compromise under which it has pledged to pay for potassium iodide for states that want it.

The NRC is still finalizing plans to implement that policy. Meanwhile, the Health and Human Services Department is considering buying some of the drug to add to its own anti-terrorism stockpiles. However, there is debate about whether the drug could be distributed from these regional stockpiles quickly enough to do any good.

The most aggressive plan would be to follow several European countries in distributing the drug to every household. But American experience suggests that would be a difficult policy to maintain over the long term. Tennessee launched such a program in the early 1980s for people living near nuclear plants, but participation has dropped to about 5 percent of households.

Tennessee maintains stockpiles near its emergency shelters, however, and is confident it could make the drug available quickly to large numbers of people.

"It doesn't seem like very much of a burden, what we're doing," said Ruth Hagstrom, the state health administrator who would give the order if potassium iodide ever had to be used in Tennessee. "We're sort of happy with the way we do things, and we wonder why everybody else doesn't do it, too."