Suppliers of Potassium Iodide Catch Up after Japan Tsunami

By Tim Donald

A ferry rests amid destroyed houses in Miyako in Iwate, the second-largest prefecture in Japan, after the 9.0 earthquake and subsequent tsunami that struck March 11.

Orders are being filled, but government stockpiles may be inadequate, manufacturers say

Suppliers of potassium iodide (KI) medications in the United States are meeting the demand for their products after being swamped with orders in the wake of the radiation leak in Fukushima, Japan, following March’s earthquake and tsunami. However, U.S. stockpiles of KI are expiring, and manufacturers and legislators have expressed concerns about whether current stocks would be sufficient to protect the public in the event of a nuclear accident in this country.
In the wake of the massive earthquake and tsunami that damaged the Fukushima Daiichi nuclear power plant in Japan, the two U.S. companies that produce KI medications experienced a tremendous spike in orders. Officials of Anbex Inc. of Williamsburg, Va., and Fleming Pharmaceuticals of Fenton, Mo., told CNN at the time that they were inundated with calls and orders after the incident, which has been called the worst nuclear emergency in Japan since World War II and the worst in the world since Chernobyl.
The two companies are the only suppliers of KI medications with U.S. Food and Drug Administration (FDA) approval. Anbex produces 130 mg iOSAT KI tablets, and Fleming produces an oral solution, ThyroShield. KI has been found to protect the thyroid, especially in young children, from the cancer-causing effects of radioactive iodine that would be released in a nuclear emergency.
Both companies now report that their KI products are back in stock and that they are filling orders after experiencing a mad scramble in the wake of the Japanese emergency.
“We had a significant increase in business [after the Japan incident]. Currently we have no trouble, we have plenty of tablets,” said Alan Morris, president of Anbex.
Deborah Fleming Wurdack, chief administrative officer of Fleming Pharmaceuticals, agreed. “Really, it was a frenzy, and as expected, it has quieted down,” she said. “Orders are not up much over last year now that we’ve made it through that rush period. It’s funny how people react.”
Fleming Wurdack said most orders during the rush came from U.S. companies that wanted the product for their employees working in Japan. Some orders also came from companies on the West Coast concerned about radiation reaching the United States via the jet stream. A few large companies ordered the product for their employees stationed all over the country. “They decided it would be a good thing to stockpile,” she said.

Counterfeit Concerns

In times of drug shortages, counterfeit concerns come to the fore. Both companies said they deal with trusted suppliers and have few concerns about the legitimacy of their raw materials.
“We make sure that we don’t buy anything that could be counterfeit. We do quantitative and qualitative analysis of everything we get in, and we know it’s real stuff,” Morris said.
“We deal with all FDA-approved suppliers, so they do keep track” of where their materials are coming from, Fleming Wurdack said. “During the peak of the frenzy we watched eBay to make sure there weren’t counterfeit products out there. We found one or two and contacted them immediately, and they pulled their products off of eBay. Because there are only two FDA-approved products in the United States, it’s pretty easy to keep an eye on.”

Stockpiles Adequate?

Both Morris and Fleming Wurdack said their companies are prepared to ramp up production again in the event of a similar emergency in this country. Morris, however, expressed concern over whether increased production would be sufficient to meet needs.
“I don’t know what the demand parameter would be,” he said. “We could fill a certain level of demand, and above that we couldn’t fill. And the government wouldn’t have [KI], and lots of people would get cancer.”
Morris and Fleming Wurdack both noted that many currently stockpiled KI medications in this country are nearing or have reached their expiration dates.
About a third of the ThyroShield stockpile has expired, Fleming Wurdack said, and the other two-thirds will expire within about the next 12 months. “None of what has expired has been replaced by the federal government,” she said. “There are states that have replaced some of theirs.”
Upon request, the Nuclear Regulatory Commission (NRC) supplies a certain quantity of KI at no charge to states, she explained.
“[ThyroShield] has been disseminated to a large number of states, but the federal government has not renewed the contract with us and has not replenished the supply, so the burden has fallen on the individual states; if they want to have a fresh supply, they have to purchase it themselves. We have taken orders from several states to replenish their expiring stocks,” she said.
Regarding KI tablets, Morris said, “The government has replaced some of it, but they have not replaced everything.” He went further, saying, “There are stockpile supplies in the U.S., but they are terribly inadequate. They are a fraction of what they would have to be in a serious nuclear accident. The government knows that, of course, but they have not acted appropriately.”
Fleming Wurdack agreed, although in a more measured tone.
“Even if they stockpiled enough, let’s say, for those within a 20-mile radius of a nuclear power plant, the jet stream could carry it certainly much further than that. The jet stream carried radiation over to this country from Japan in small amounts.”
According to the Environmental Protection Agency, “trace amounts of radioactive isotopes consistent with the Japanese nuclear incident … far below levels of public health concern” were detected at air monitoring stations across the country as of March 28. At this time, the Centers for Disease Control and Prevention “does not recommend that people in the United States take [KI] or iodine supplements in response to the nuclear power plant explosions in Japan.”

Addressing Supply

Morris applauded the efforts of Rep. Edward J. Markey, D-Mass., and others in Congress to address the KI supply issue. Thirty members of Congress, led by Markey, sent a letter to President Obama on May 9, asking him to implement a law passed in 2002 that would increase supplies of KI at nuclear sites in this country.
“Although this law has been on the books since 2002, it has, inexplicably, yet to be implemented,” the letter states.
Markey was the author of an amendment to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 calling for KI to be made available to state and local governments to meet the needs of people living within a 20-mile radius of a nuclear power plant. That provision of the law was never implemented by the administration of George W. Bush, and so far the Obama administration has upheld the Bush administration’s position on the issue.
Before that law was passed, distribution of enough KI to cover those living within a 10-mile radius of a nuclear plant was allowed to states that requested it from the NRC, according to a May 10 press release from Markey’s office.