Vaccine Crisis Developing

By Marilyn Werber Serafini, National Journal

WASHINGTON — In 2004, a 16-month-old boy died of pneumonia at the Children's Hospital of Philadelphia. He shouldn't have passed away — and therein lies a cautionary tale about the threat of avian flu. The toddler was infected by a bacteria called pneumococcus. Before 2000, pneumococcus was often a death sentence. Worldwide, more than 1 million children died every year, according to the World Health Organization. The situation changed dramatically in 2000, when the pharmaceutical giant Wyeth brought to market a revolutionary vaccine that guarded against pneumococcus in young children. Suddenly, parents and doctors with access to the vaccine no longer had to fear pneumococcus as a killer (see GSN, Feb. 22).

But in 2004 the vaccine was in short supply, and the Philadelphia toddler received only two of the recommended four doses. “The pneumococcus isolated from the child’s blood was a type that could have been prevented by the vaccine,” Paul Offit, chief of the division of infectious diseases at Children’s Hospital, wrote in a 2005 book called “The Cutter Incident,” named after a vaccine manufacturer that was sued in the 1950s over its polio vaccine. If the vaccine were made by several companies, he wrote, “children wouldn’t have to rely on the production efficiency of one company to save their lives.”

To the dismay of public health officials, vaccine shortages have become routine in the United States. Most vaccines now come from only one producer, and that leaves no margin of error when things go wrong in the production process — and they sometimes do. Between 1998 and 2004, nine of the 12 vaccines routinely given to children were in short supply at one time or another. The Centers for Disease Control and Prevention reported shortages of vaccines for chickenpox, diphtheria, flu, measles, mumps, pertussis, rubella (German measles), pneumococcus, and tetanus.

Over the past three decades, the vaccine infrastructure in the United States has steadily crumbled, and as Americans learn more about the deadly avian flu, concern about vaccine availability has escalated to fear, and even panic. The companies that would make vaccines for pandemic flu are the same ones that make seasonal flu vaccines, and only one of those suppliers — Sanofi-Pasteur, the vaccine division of Sanofi-Aventis — makes it entirely in the United States.

“We have very limited manufacturing capacity right now as a world or as a nation” to make flu vaccine, Bruce Gellin, director of the national vaccine program office at the Health and Human Services Department, told National Journal. And many experts worry that in the event of a pandemic, flu vaccine makers in other countries would be forced to keep their supplies at home.

In the 1950s, 26 companies made vaccines in the United States. By 2004, only four — GlaxoSmithKline, Sanofi-Aventis, Merck, and Wyeth — remained. The winter of 2000-01 was the last flu season in which the United States had more than one domestic flu vaccine supplier, and after that it didn’t take long for demand to outstrip supply. The first shortage came the following year, when only Sanofi-Pasteur was making vaccines in the United States. The situation got worse in 2003-04, when influenza hit early and media reports of children dying sent both the young and the old scrambling to vaccine clinics. Sanofi made 48 million doses that season, and a small British company — Liverpool-based Chiron — produced 35 million doses for the U.S. market. Clinics had to turn away many vaccine-seekers. The next year proved even worse, when Chiron had to scrap its entire lot because of bacterial contamination.

The shortages are “a warning signal, a harbinger,” Offit said. If a flu pandemic struck today, Sanofi could make a vaccine, Gellin said, but only enough for about 15 million to 20 million of America's 300 million people. “If there's a pandemic, who else would make [the vaccine] but us?” asked Wayne Pisano, Sanofi's senior vice president of commercial operations.

Offit recalled how scientist Maurice Hilleman softened the blow of the Hong Kong flu pandemic in the 1950s. Hilleman discovered the new flu strain and quickly sent the virus to six U.S. vaccine makers, who produced a total of 40 million doses in five months. But today, Offit said, “if you picked up the phone you would get zero U.S. manufacturers. Everyone thinks this is the modern age — ventilators, ICUs. It doesn't matter.  Prevention is the only way you can stop this.”

As alarm about avian flu intensifies, lawmakers are starting to pay attention. “This has caused a teachable moment where policy-makers begin to listen — Democrats and Republicans,” said Senate Majority Leader Bill Frist (R-Tenn.) In December, Frist, who is a heart-lung transplant surgeon, pushed a bill through Congress to grant vaccine makers protection from liability in a pandemic. He plans to advance two more pieces of legislation this year aimed at spurring vaccine producers to step up development and production. “We need to shorten the bug-to-drug interval ... because it’s the difference between life and death,” Frist said. “We are going to see [avian flu] in our birds here sometime in the next year. ... There's an immediate crisis coming at us right now.”

But legislating this year won't be easy. Even Frist's liability protections became law over the opposition of a number of lawmakers. Consumer groups complained that the government is bowing to the drug industry and leaving little legal remedy for people who might be injured by vaccines.

In October, President George W. Bush made a personal plea to drug industry leaders at the White House, urging them to make more vaccines. The Health and Human Services Department has approved a handful of grants to help get them started, and drugmakers are beginning to respond. Sanofi is building a new plant and expanding capacity; GlaxoSmithKline has purchased a flu vaccine facility in Quebec that would supply the United States. But there’s a long way to go, and company executives say that in addition to liability protections, they need antitrust exemptions in an emergency, so that they can talk, plan, and even produce together. They also want some guarantee that their vaccines will be purchased, even if they are never needed.

Everything comes down to money, and vaccine production hasn't traditionally been a lucrative business. Why build an expensive plant to make a vaccine that requires only one or two doses, or a vaccine for a pandemic flu or bioterrorism-related event that may never materialize? Pharmaceutical companies would rather invest in a drug that people take every day for a chronic condition such as high cholesterol.

The cost of researching and developing a vaccine can be high. Because scientists must grow the viruses in live eggs or cells, ensuring consistency is difficult. Regulatory oversight is rigorous. But the biggest deterrent to vaccine production, according to pharmaceutical company executives, is the threat of multimillion-dollar lawsuits.

“The vaccine industry today is [worth] $6.7 billion, approximately, and lawsuits out there add up. Damages being sought exceed $30 billion, total,” said Sanofi's Pisano, citing a compilation of drug manufacturers' annual reports. Drugmakers say that the new law championed by Frist only partially fixes the problem. The liability shield operates only when the HHS secretary declares a pandemic or the threat of one. The legislation doesn't address, for example, whether the liability protection would cover seasonal flu vaccines.

Liability wasn't always a big concern. Drugmakers were generally willing to produce vaccines until the first polio vaccine generated expensive lawsuits. To combat a virus that was paralyzing more than 21,000 Americans a year, five companies introduced vaccines for polio in 1955. But some of the first vaccines produced by Cutter Laboratories infected 220,000 people with polio; 164 were permanently paralyzed, and 10 died.

In 1956, Josephine and Robert Gottsdanker sued Cutter for injuring their daughter Anne, who became paralyzed after taking a Cutter vaccine. In 1958, a jury, acknowledging that the company had not acted negligently, nevertheless found Cutter liable. “The Gottsdanker verdict meant that if pharmaceutical companies made a product according to industry standards, using the best science that was available, and found months or years after its sale that it caused harm -- a harm not predictable -- they were liable for the damage,” Offit wrote in “The Cutter Incident,” which traces today's vaccine crisis back to the polio epidemic.

Legal experts at the time predicted that the precedent of "liability without fault” would discourage drug companies from taking on the risk of developing new vaccines. Cutter was faced with dozens of suits but managed to pay off the $3 million in liability through insurance and loans. A company called Lederle, though, didn't fare as well. Lederle’s vaccine for pertussis, or whooping cough, became the target of controversy in the 1970s when a British researcher charged that the vaccine caused swelling of the spinal cord. The claim was never substantiated, but by 1987, plaintiffs had filed 800 lawsuits totaling more than $21 million against the manufacturer. A jury in the United States awarded $1.13 million to Kevin Toner, who became paralyzed from the waist down after receiving the vaccine in 1979 at the age of 3 months. The award equaled more than half of the $2 million in gross sales from pertussis vaccines in the United States.

While awards were growing larger, federal regulation was getting tougher, making it even more expensive for vaccine makers to stay in business. “Vaccines are arguably held to a higher standard of safety than any other product given to children, including antibiotics and cough-and-cold preparations,” Offit wrote. “Vaccines undergo thousands of tests to make sure that they contain exactly what they are said to contain; they are tested in tens of thousands of people before they are licensed, to make sure that they are safe and that they work; and they are watched very carefully after licensure — when they are given to millions of people — to make sure that they don't cause any rare side effects.”

After pharmaceutical companies began abandoning vaccines, Congress responded in 1986 with the National Vaccine Injury Compensation Program: If a panel of experts found that a child had been injured by a vaccine recommended by the CDC, the government — not the producer — would compensate the family for medical expenses and damages.

The law improved the liability situation for makers of children's vaccines, but drug companies say that it still doesn't give them all the protection they need. They add that the program also caused another problem when it authorized the government to purchase vaccines for low-income children. The government established low prices for staple vaccines years ago, and drugmakers complain that no system exists to adjust the prices for inflation. As a result, doses of vaccines that were introduced years ago cost $10 to $20, while newer vaccines are priced from $50 to $70. The government's Vaccines for Children Program purchases about half of all vaccines recommended for kids, including flu vaccines.

Drugmaker Pfizer is a “poster child for the unintended consequences of vaccine policy in this country,” wrote Pfizer Chairman Hank McKinnell in his 2005 book “A Call to Action.” Pfizer is a top producer of vaccines for animals, but it stopped making vaccines for humans. “The difference between the two sectors could not be starker. Animals don't file lawsuits, and there is no single-source buyer for animal health vaccines,” McKinnell said.

“No industry is likely to invest in complicated research projects if it has little reason to think it will recoup its costs, much less show a return,” McKinnell maintained. Warner Lambert (now Pfizer) sold its flu vaccine business in 1998 to King Pharmaceuticals, which ceased production because bringing its plant into federal compliance was too costly, according to an article by Alexandra Minna Stern and Howard Markel in the May/June 2005 issue of the journal Health Affairs.

People are less willing to accept risks with vaccines than with other medications, according to McKinnell. “Because vaccines are given to large numbers of healthy people,” he wrote, “safety and liability concerns can seem greater than with drugs that are given to sick people, who are willing to bear some risk of side effects to get better.”

Billy Tauzin, a former Republican House member from Louisiana who is now president of the Pharmaceutical Research and Manufacturers of America, took a risky drug a couple of years ago when he was facing an aggressive cancer. “I had to decide with my oncologist to take a medicine that could have killed me. ... We judged the risk-benefit, and it was a good one, and I'm alive. With vaccines, you're basically giving this medicine to a healthy patient. And you know in advance that a certain percentage of those patients are going to have a bad reaction,” he said.

“Everyone needs to think about how awkward an economic model we're talking about here,” Tauzin added. “We're talking about products we hope people will never need and people will never buy. And spending research-and-development money on these new products, and building manufacturing facilities for them, and maintaining those factories ... having to revise your molecules to keep up with a mutating virus. And all that in an economic model that says you hope people never have to buy” the vaccine.

To jump-start vaccine production, policy-makers are focusing on three areas: limiting drugmakers’ burdens of legal liability; increasing government investment; and easing antitrust restrictions in an emergency. The struggle will be to find the right balance of helping the drug industry while protecting consumers.

The Frist-backed bill that became law in December shields vaccine makers from liability if the secretary of Health and Human Services declares a pandemic or epidemic, or certifies a risk of pandemic or epidemic. The shield would apply to all medical devices, drugs, or vaccines used to prevent, treat, or cure the illness or its side effects.

Without liability protections, Sanofi would take the usual 10 years or so to run through full development and extensive clinical trials to ensure the safety of a pandemic vaccine — and that would be too late, acknowledged Pisano. But with the protections, “for something like a pandemic, we would [make a vaccine] in less than two years. We wouldn't go through all the rigorous testing we would like to do.”

Some members of Congress and consumer advocates say that the Frist bill, which was attached to a Defense Department appropriations bill as Congress rushed to adjourn for the year, went too far. Opponents may try to revisit the issue on Capitol Hill. “It's outrageous.  It was special-interest legislation put in in the dead of night,” Senator Edward Kennedy (D-Mass.) told National Journal. Representative Henry Waxman (D-Calif.), who sits on the Energy and Commerce Committee's Health Subcommittee, complained, “Industry greed is running rampant. ... A lot of people should be worried about it.”

Jillian Aldebron, legislative counsel for Public Citizen's Congress Watch, complains that the law leaves little recourse for injured vaccine takers. “If you're taking Tylenol for a headache that you get from avian flu,” for example, “you cannot sue if you got Tylenol from a defective batch. Moreover, she said, while the law has a provision to compensate injured people, it is meaningless because Congress hasn't funded it. “They can point to it and say they provided compensation, but you can't sue anyone. ... Imagine talking about an avian-flu pandemic — you know things will be rushed out to market under relaxed [Food and Drug Administration] approval standards,” she said. “How do we know these things will be safe? Killing people in the name of saving them from another deadly disease hardly seems rational.”

The liability shield is also unnecessary, Aldebron argues. She contends that HHS already had the authority to indemnify companies so that the federal government would shoulder the responsibility for injuries. And even before the Frist bill passed, she said, Sanofi had signed a $100 million contract and Chiron had signed a $65 million contract with HHS to deliver more flu vaccine.

Frist said his next step will be to bring up legislation that Senator Richard Burr (R-N.C.) is preparing. Burr's bill would create a Biomedical Advanced Research and Development Agency within HHS to coordinate research priorities. BARDA would get around what Burr calls the “valley of death.” He explains that after a pharmaceutical company completes the basic research into a vaccine, oftentimes it cannot afford to take the next steps: advanced research and expensive clinical trials. Burr proposes moving $1 billion from the federal government's Bioshield program to BARDA. Bush signed Bioshield into law in 2004 to authorize the Homeland Security and Health and Human Services departments to purchase medicines and vaccines to guard against chemical, biological, radiological, or nuclear attacks. Bioshield does not cover a naturally occurring pandemic.

Burr’s bill has stirred a debate about whether Bioshield money should be invested at the “back end,” to buy products already on the market, or be used to encourage promising research into new medicines and vaccines. The Bioshield Act permits HHS to use $500 million for advanced research, but, said a Burr aide, “HHS is reluctant to do so because it takes away from their procurement dollars. If they use [their budget] for advanced development, they can buy less stuff. But you pay for it either way.

“Procurement includes basic research and everything else that goes into it. The point of paying for it now is to ensure no delays, to expedite the development of this product,” the aide argued. But Burr acknowledged that persuading his colleagues to support using Bioshield money for advanced pharmaceutical research instead of procurement will be a hard sell.

Separate from Bioshield, the Bush administration already is promoting advanced research on vaccines. The Burr aide reported that he was told by National Institutes of Health staff that one-third of the $4.3 billion budget of the National Institute of Allergy and Infectious Diseases goes to advanced research. And Bush's fiscal 2007 budget request asked Congress to cut spending for all NIH institutes except NIAID, and to give the NIH director $160 billion to spend on advanced research. This shows that Bush “understands the need,” Burr said. But the senator argues that NIH is the wrong entity to guide advanced research and that it should return to its traditional mission of basic research.

After Frist moves Burr's legislation forward, the majority leader plans to bring back a second Bioshield bill to address other issues. In its current form, the legislation would give lengthier patents to pharmaceuticals and vaccines that are considered countermeasures to terrorism-related illnesses. It would establish a commission on countermeasure and vaccine regulation, and would allow tax credits for vaccine and countermeasure manufacturing and research. The legislation also would ease antitrust rules for companies working on countermeasures, so that companies could join efforts to quickly develop and produce countermeasures in an emergency. Meetings between the Health and Human Services secretary and entities developing priority countermeasures would be exempt from antitrust law.

Even while Congress this year tries to prod drug companies to produce vaccines, a longer-term problem is escalating. Whether drugmakers are entering the vaccine business for the first time or expanding existing capacity, new vaccines will cost more to produce, and all parties are already showing a reluctance to pay.

“The concern is, at some time this will break the bank,” said Walter Orenstein, director of Emory University's program for vaccine policy and development. He asserts that policy-makers need to begin grappling with the question of who should foot the bill. “The big issue to me that needs to be solved is financing,” he said. Over the last 10 years, the CDC has greatly expanded the number of vaccines it recommends for children, including varicella, pneumococcal, flu, adolescent meningococcal, pertussis, hepatitis A, and rotavirus vaccines. A human papillomavirus vaccine for adolescents is expected shortly.

The federal government's Vaccines for Children Program spent $500 million in 2000 and $1 billion in 2002, according to a 2004 report, “Financing Vaccines in the 21st Century,” from the National Academies' Institute of Medicine. Despite the benefit of vaccines, Bush in his fiscal 2007 budget proposal recommended a decrease in funding for one subsidy program, Orenstein complained.

The Institute of Medicine's report also addresses the reality that insurers are spotty in their vaccine coverage. The institute recommends a new mandate for all public and private insurers to cover vaccines, and it proposes that the federal government reimburse insurers for the cost of purchasing vaccines and provide vouchers so that uninsured people could be vaccinated.

“It's going to have to be a partnering,” Frist countered. “I would have the federal government be a partner in the purchase of vaccines, and not the sole purchaser. We need to have the element of the marketplace in it. If we say the federal government will take care of this, it will discourage the private sector.”

Toward that end, PhRMA's Tauzin is floating an idea to get consumers more involved. He proposes that people buy insurance for various vaccines, even ones that are not yet on the market. Insurance companies would use those premiums to invest in vaccine manufacturers' research and production. The insured consumer would then win a place on a list if one of the vaccines goes on the market.

With avian flu looming, the federal government is stepping in with contracts to buy pandemic vaccine. But whether it’s government, insurance companies, or individuals writing the checks, Orenstein emphasizes, the price is getting higher. The cost of vaccines is the main issue, he says.

Ultimately, many Americans believe that the federal government should take the responsibility to ensure an adequate supply of flu vaccine, according to a survey by the Harvard School of Public Health during the flu vaccine shortage of 2004. Nearly half (45 percent) of respondents said that the federal government’s public health agencies should be primarily responsible; 26 percent put the onus on vaccine manufacturers and pharmaceutical companies.

Public health officials are relieved that the issue of vaccine capacity has finally grabbed the spotlight. But even with Washington working feverishly, it’s impossible to say whether policy makers and the private sector can beat the arrival of the next pandemic.

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U.S. Moves on Swiss Firm for North Korea WMD Ties

The Bush administration yesterday imposed sanctions on a Swiss industrial wholesale company and its president for allegedly assisting North Korea in WMD proliferation, the Associated Press reported (see GSN, Jan. 23).

The U.S. action, intended to increase pressure on Pyongyang, freezes all assets within the United States of Kohas AG and president Jakob Steiger. U.S. companies are also barred from conducting business with the firm.

“North Korea's efforts to build and sell weapons of mass destruction depend on a vast network, the reach of which extends beyond Asia,” said Stuart Levey, the Treasury Department’s undersecretary for terrorism and financial intelligence.

Treasury maintains that Kohas has ties to Korea Ryonbong General Corp., a North Korean company that had its assets frozen by the United States last year.   The United States believes this company has participated in transactions that promote WMD proliferation.

A Korea Ryonbong General subsidiary, Korea Ryongwang Trading Corp., owns nearly half the shares of Kohas, according to the Treasury Department. The United States last year also blocked the subsidiary.

“Kohas AG acts as a technology broker in Europe for the North Korean military and has procured goods with weapons-related applications,” the department said in a release. “'Kohas AG and Jakob Steiger have been involved in activities of proliferation concern on behalf of North Korea since the company's founding in the late 1980s” (Associated Press/New York Times, March 30).

Othmar Wyss, an official with the Swiss Economics Ministry who is responsible for export controls and sanctions, said the U.S. action was unfounded, the Associated Press reported.

He said that Swiss authorities have monitored the company for the last 10 years and found no evidence of a connection to North Korean WMD proliferation (Associated Press, March 31).

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Jury in Moussaoui Case Seeks Definition of WMD

Jurors deliberating whether al-Qaeda conspirator Zacarias Moussaoui should receive the death penalty or life in prison for his role in the Sept. 11 attacks yesterday sought a definition for weapons of mass destruction, the Associated Press reported (see GSN, June 13, 2005).

U.S. District Judge Leonie Brinkema said airplanes used as missiles constitute such weapons. Moussaoui has been convicted of conspiracy to use weapons of mass destruction, one of three convictions that could earn him the death penalty, AP reported (Michael Sniffen, Associated Press/Philly.com, March 31).

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Pentagon to Detonate 700-Ton Explosive

The U.S. Defense Department is scheduled on June 2 to explode a 700-ton explosive to test the capability of a huge conventional bomb to destroy deeply buried facilities that could contain weapons of mass destruction or other threats, the Washington Post reported today (see GSN, March 24).

The detonation of heavy ammonium nitrate-fuel oil emulsion would be the largest ever open-air chemical explosion conducted at the Nevada Test Site.

“This is the largest single explosive we could imagine doing,” James Tegnelia, director of the Defense Threat Reduction Agency, said yesterday.

A powerful conventional weapon could be an alternative to the Robust Nuclear Earth Penetrator, which the Bush administration has promoted as the best option for eliminating underground, hardened enemy facilities. U.S. lawmakers have blocked funding for study of the “bunker buster” in favor of non-nuclear weapons.

Tegnelia indicated that a conventional bomb might not be up to the task of eliminating underground facilities as a threat, the Post reported. “It’s a lot easier to dig your tunnel 50 feet deeper” than to produce new weapons able to reach that added depth, he said.

The test, to be called “Divine Strake,” would produce an explosion equal to that of 593 tons of TNT in a 36-foot-deep hole. Officials stressed the conventional nature of the test.

“The U.S. has no plans to conduct a nuclear test. President [George W.] Bush supports a continued moratorium on nuclear testing,” said DTRA spokeswoman Irene Smith (Ann Scott Tyson, Washington Post, March 31).

While the state has signed off on the desert test, U.S. lawmakers from Nevada expressed concerns about the size of the explosion, the Associated Press reported.

“I am concerned that tests of this magnitude have been planned without providing Nevadans with any information about the possible impact on their health and safety,” said Senate Minority Leader Harry Reid (D-Nev.), in a prepared statement.

“Given the level of contamination in areas where nuclear tests were conducted, I have real concerns about the dust and other pollutants that will be released into the air as a result of this explosion,” said Representative Shelley Berkley (D-Nev.) (Kathleen Hennessey, Associated Press/Yahoo!News, March 31).

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Lawmaker Warns Against Developing New U.S. Nukes

By David Ruppe
Global Security Newswire

WASHINGTON — A key U.S. congressman, who led successful opposition to the Robust Nuclear Earth Penetrator program last year, yesterday sharply warned the Bush administration against any ambitions to build new nuclear weapons capabilities through its Reliable Replacement Warhead program (see GSN, March 2).

“This is not an opportunity to run off and develop a whole bunch of new capabilities and new weapons.  This is a way to redo the weapon capability that we have and maybe make them more reliable, make them better mission capable,” said Representative Dave Hobson (R-Ohio), chairing a hearing of the House Appropriations Energy and Water Development and Related Activities Subcommittee.

The Bush administration has described the Reliable Replacement Warhead program as an effort to develop new nuclear weapons and components to replace components of the existing arsenal, with the purposes of increasing U.S. nuclear weapons reliability, speed of manufacture, serviceability and security, and improving the weapons complex so new weapons could be more quickly developed for new missions. 

The Robust Nuclear Earth Penetrator study was intended to determine whether existing nuclear weapons could be modified for greater reliability of exploding after slamming into hard earth in order to destroy deeply buried, hardened facilities.  The Energy Department formally canceled that program last month, after Hobson led congressional efforts for two consecutive fiscal years to deny it any funding, according to a congressional report (see GSN, March 24).

Hobson applauded the administration’s decision this year, under pressure from Congress, to terminate the Robust Nuclear Earth Penetrator feasibility study.

“NNSA and DOD took the first steps towards transforming the weapons complex this winter by finally working with the Congress to terminate the nuclear ‘bunker buster’ proposal.  I think DOE and DOD, the Congress, the American people, and frankly, the world, are better off because of this policy change,” he said.

While the Reliable Replacement Warhead program should be permitted to produce “enhanced capability,” Hobson said, “I don’t want any misunderstandings as to media coverage of these things, and … sometimes within the department, people hear only what they want to hear. … We’re not going out and expanding a whole new world of nuclear weapons as we get in[to] this Reliable Replacement Warhead situation.”

Testifying before the committee, National Nuclear Security Administration chief Linton Brooks responded by “stressing that [the] reliable replacement concept envisions the same military capabilities on the same delivery systems, holding at risk the same targets.  And it’s not the beginning of a new round of new weapons.”

Critics have said the program could produce new weapons capabilities and have noted it is intended to help facilitate changes to the U.S. nuclear weapons complex that would enable it to more rapidly design, develop and produce new weapons types if a decision were made to do so.

Two other congressmen at the hearing noted a chart sent by Brooks’ agency to the committee shows much of the current nuclear stockpile would be reduced and replaced by reliable replacement warheads.

Separately, Hobson criticized the U.S. nuclear weapons complex for “resistance to change,” in particular; to implementing the recommendations of an Energy Department nuclear weapons infrastructure task force. The Secretary of Energy Advisory Board in July 2005 called for the immediate design of a Reliable Replacement Warhead, building a consolidated nuclear weapons production facility housing key nuclear weapons components, and more aggressive dismantlement of the Cold War stockpile.

“I’ve been very disappointed by the apparent disinterest of the NNSA in implementing the recommendations,” Hobson said.

“The current complex, in my opinion, is too large for any conceivable future need, and much too inefficient to be maintained, given shrinking federal resources,” he also said.

Brooks said his agency is working on a “vision of the future nuclear weapons complex,” which he said would draw “heavily, though not completely,” on the task force recommendations, and which would be presented at a later hearing.  

Brooks said he believes a new capability would be needed in the future for mass production of plutonium cores for nuclear weapons, “to include the ability to produce pits both for reliable replacement of warheads and because of the as-yet not fully understood consequences of pit aging.”

Critics recently have argued a new production capability is not needed, citing yet-unpublished work by Lawrence Livermore National Laboratory researchers suggesting plutonium pits should be reliable for decades longer than the previously thought 45 to 60 years.

Brooks has said previously the government has not yet reached a conclusion on plutonium pit aging.

Hobson also criticized the administration for not heeding congressional direction in the fiscal 2006 energy and water appropriations conference report on a funding increase for the Y-12 nuclear weapons production plant. He urged the administration to “fulfill the will of Congress after Congress fulfills its constitutional duty by passing a budget.”

“This year the Department of Energy seems to have decided to follow what I think is a very dangerous path of ignoring or maliciously complying with congressional direction in the fiscal year 2006 bill.  And I will promise you all that is a very short-sighted and possibly disastrous policy to follow,” he said.

“And I expect the department to implement the programs and execute the budget in a way that reflects the law and the congressional intent, because if you read the Constitution, it doesn’t give the departments the ability to violate the law or the intent of the law.  And if this Congress has to start going after people, we will,” he said.

Brooks told the committee, “We’re committed to carrying out the will of the Congress.  It happens from time to time that individual decisions, when they are added together, don’t fit, and that [in] time we try to make them fit, and clearly in this case that’s what we’re trying to do.  I think that I am committed to continue to work with you and with the committee on the specifics, and I also look forward to working with the committee staff to avoid the situation in the past — or in the future.”

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Differences Simmer in U.N. Security Council on Iran

Disagreement on how to handle Iran’s potential resistance to a demand for Tehran to stop nuclear activities within 30 days has emerged among members of the U.N. Security Council, Agence France-Presse reported yesterday (see GSN, March 30).

Foreign ministers from the five permanent U.N. Security Council members and Germany met in Berlin yesterday to consider the issue.

Russia and China argued that Tehran must not face sanctions if the declaration is not followed.

“Russia does not believe that sanctions would serve the purpose of settling the various issues,” Russian Foreign Minister Sergei Lavrov said.

Lavrov questioned U.S. accusations that Iran’s nuclear program is specifically targeted at developing weapons, the Associated Press reported.

“Before we call any situation a threat, we need facts … (and) so far they have not been provided,” he said (George Jahn, Associated Press/Yahoo!News, March 30).

Chinese Deputy Foreign Minister Dai Bingguo warned that use of force against Iran would hurt the situation. “The Chinese side feels there has already been enough turmoil in the Middle East and we do not want to see more turmoil introduced into the region,” he said.

International Atomic Energy Agency chief Mohamed ElBaradei joined the opposition to sanctions, AFP reported.

“Sanctions are a bad idea. We are not facing an imminent threat,” he said. 

A senior U.S. State Department official said that all nations meeting in Berlin shared an “acute concern” over Iran’s nuclear program. “A number” of ministers, including U.S. Secretary of State Condoleezza Rice, argued that sanctions need to be considered at some time.

“I am not saying there is unanimity about this. But what was interesting was that (the) issue was joined for the first time at a P-5 meeting,” the official said.

It is not known what would happen if the 30-day deadline passes and Iran has not stopped uranium enrichment activity.

“We are thinking about positive steps as well as negative steps, in conjunction with Russia, with China and with all other partners, depending on Iran's response,” said French Foreign Minister Philippe Douste-Blazy.

Iran has indicated it does not plan to obey the U.N. demand. Iranian Foreign Minister Manouchehr Mottaki yesterday said the U.N. declaration was an “angry precedent” and a “bad move.”

Rice, on the other hand, called the declaration “a strong sign to Iran that negotiation not confrontation should be their course.”

“It is now up to Iran to make a choice ... between isolation brought about by its own actions or a return to the negotiating table,” said German Foreign Minister Frank-Walter Steinmeier.

British Foreign Secretary Jack Straw said Tehran had “miscalculated” the resolve of the Security Council members.

“They thought the international community would be divided on this issue but, truthfully, it has become more and more united,” Straw said.

U.N. Secretary General Kofi Annan, speaking in New York, praised the “spirit of consensus” among members of the Security Council.

He said Tehran must “heed the international community's concerns” and “cooperate fully with its obligations under the Nuclear Nonproliferation Treaty and successive International Atomic Energy Agency resolutions” (Agence France-Presse I/TODAYOnline.com, March 30).

One official involved with the talks in Germany said “there was lots of heated discussion in the meeting” about what to do if Iran misses the deadline, the Financial Times reported.

“This isn’t the time to try and come to a conclusion about what the next step is,” Rice said. “It’s an opening discussion about those next steps” (Financial Times, March 31).

Gregory Schulte, U.S. ambassador to the U.N. nuclear watchdog, said the Security Council should consider sanctions if Iran does not stop nuclear activity, AFP reported.

“For diplomacy to succeed we will need to use the full range of diplomatic tools available to the Security Council,” he said today in Budapest.

“We will need to use the tool of transformation diplomacy from financial measures to the proliferation security initiatives to target Iran's procurement networks,” he added.

However, Schulte did not rule out a diplomatic solution to the standoff.

“The opportunity for a negotiated solution is still on the table,” he said (Agence France-Presse II, March 31).

Iranian Foreign Minster Mottaki yesterday formally offered to establish a “regional consortium” to enrich fuel for Tehran, which apparently would operate from within Iran, AFP reported.

Mottaki, referring to a previous proposal from Tehran on the “involvement of foreign companies in the Iranian fuel cycle program,” said, “One possibility to resolve the issue could be the establishment of a regional consortium on fuel-cycle development.”

The partnership would involve “regional countries which have already developed fuel cycle programs at the national level and intend to develop further their program for civilian purposes,” he said.

“Countries outside the region may also participate in such regional arrangements based on the modalities agreed between the parties,” Mottaki added.

Mottaki did not offer details or the names of countries that would be involved (Agence France-Presse III/OutlookIndia.com, March 30).

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Indian Official Defends Nuclear Deal

Indian Foreign Secretary Shyam Saran, in Washington to promote the U.S.-Indian nuclear sharing agreement, said yesterday the proposed deal would not spark a nuclear arms race in South Asia, Reuters reported (see GSN, March 30).

Saran also reaffirmed India’s vow not to conduct nuclear weapons testing and said India might accept congressional conditions on the deal that do not upset the “delicate balance” of the agreement.

“We have not indulged in a nuclear weapons race before this agreement was arrived at (and) there is no reason why it should be expected that merely because we have an agreement on civil energy cooperation, that suddenly the floodgates would be opened by India for a larger and larger arsenal,” he said at a Heritage Foundation event.

The White House assumption that the benefits from the deal would outweigh its risks is “every bit as consequential as the decision to topple” Iraq, Michael Krepon, a nonproliferation expert at the Henry L. Stimson Center, said in an online statement. He said the deal — which must be approved by Congress and the international Nuclear Suppliers Groups — would hand India a “free pass” to produce fissile material, expand its nuclear stockpile and test weapons.

Other experts have said they worry that the U.S. pledge to supply India with nuclear fuel indefinitely means Washington loses leverage to stop technology sharing if New Delhi tests another weapon.

Saran pointed out that India in the agreement vowed to continue its testing moratorium. New Delhi understands that U.S. law forbids nuclear cooperation with states that test weapons, he said.

Critics said that loopholes are contained in legislation introduced in Congress making changes to U.S. law to allow the agreement to move forward. They said Congress must have time to review the agreement.

Saran said that if U.S. legislation “is within bounds” of the agreement between New Delhi and Washington, “I think we would have no problem.” He added that India must see what changes Congress proposes (Reuters/New York Times, March 30).

Saran warned, however, that ties between the United States and India would be hurt if Congress did not approve the deal, Agence France-Presse reported.

“If this particular agreement does not go through, there is no doubt there will be, in terms of the expectation that has been created, in terms of the enthusiasm that has been created, there will be some falling back,” he said.

“If this does not go through, it does not mean that everything else will fall by the wayside but at the same time we should also recognize that for good reason or bad, there is intense focus on this particular agreement,” Saran added. 

“Therefore whether we like it or not, this has become very symbolic of what we want to do with India-U.S. relations,” he added (Agence France-Presse I/ChannelNewsAsia.com, March 30).

India is expected to begin discussions next week with the International Atomic Energy Agency on opening its civilian reactors to inspections as required by the deal, the Associated Press reported.

Anil Kakodkar, chairman of India’s Atomic Energy Commission, is expected to visit Vienna next week to meet with agency head Mohamed ElBaradei (Associated Press, March 31).

Meanwhile, a U.S. lawmaker said allegations that India recently offered training for Iranian troops could hurt the chances of the deal receiving congressional support, Agence France-Presse reported.

House International Relations Committee ranking Democrat Tom Lantos (D-Calif.) shared these concerns with Saran, according to Lantos spokeswoman Lynne Weil.

“Congressman Lantos pointed out that episodes of conflict in relations between U.S. and India, such as India’s early wavering in its commitment to refer Iran to the U.N. Security Council and more recent concerns raised about Iranian troops receiving training from India will only undermine congressional support for the deal,” Weil said.

The Indian government said that two Iranian naval ships made a six-day “informal” visit to an Indian naval base this month while training in the Arabian Sea.

The visit was “diplomatic-goodwill” and not part of any training activity, said Venu Rajamony, a spokesman for the Indian Embassy in Washington (Agence France-Presse II/Yahoo!News, March 31).

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Russia Says Nuclear Deterrent a Security Priority

Russian President Vladimir Putin said yesterday that Moscow’s highest security strategy priority is maintaining enough nuclear weapons to create a strong deterrent, the Associated Press reported (see GSN, Feb. 13).

International uncertainty demanded that Russia keeps an adequate number of nuclear arms, Putin said.  He did not say how many are needed.

Putin and U.S. President George W. Bush in 2002 signed an agreement that requires them to cut two-thirds of their deployed strategic nuclear arsenals by 2012. That would leave each nation with between 1,700 and 2,200 strategic warheads in operation.

Many experts believed when the treaty was signed that the number of Russian nuclear weapons would fall below treaty requirements. However, rising oil profits in recent years have allowed for increased Russian defense spending, AP reported. 

Putin said yesterday that Moscow was considering details of its weapons program for 2007 to 2015. He did not provide any additional information of the weapons program (Associated Press/New York Times, March 30).

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Japan Tests Nuclear Fuel Reprocessing Plant

The first full nuclear fuel reprocessing plant in Japan began a test run today under the supervision of the International Atomic Energy Agency, Kyodo News reported (see GSN, Feb. 8).

The Japan Nuclear Fuel facility in Rokkasho is scheduled to begin full operations in August 2007. It would reprocess roughly 800 tons of spent fuel annually, producing more than 4 tons of plutonium that would be mixed with uranium for nuclear power plant fuel.

The test involves reprocessing of 430 tons of spent fuel. IAEA inspectors are on hand because the extracted plutonium could be used in nuclear weapons, Kyodo reported.

The anti-nuclear Citizens’ Nuclear Information Center criticized the test.

“While the world’s attention is diverted by the nuclear ambitions of Iran and North Korea, Japan has strengthened its position among countries which wish to develop weapons-usable technologies,” the group said in a statement. “Besides the proliferation risks, the beginning of active tests also marks the beginning of large-scale radioactive pollution from the plant” (Kyodo News, March 31).

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U.S. Considers Aiding Libyan CW Disposal

The U.S. Defense Department is considering aiding Libya’s chemical weapons disposal efforts, but estimates that such assistance would cost $100 million, the Associated Press reported today (see GSN, Nov. 16, 2005).

Pentagon specialists visited Libya in late January, and are now preparing a proposal discussing ways in which the United States could help Libya meet its Chemical Weapons Convention obligation to eliminate its chemical stockpile.

“It would be a difficult thing,” said James Tegnelia, director of the U.S. Defense Threat Reduction Agency.

The site visited by the DTRA officials is in an isolated location that lacks sufficient access to water needed for chemical agent neutralization, said Peter Flory, assistant defense secretary for international security policy.

Pentagon officials declined to identify the site or say what the visiting officials found, AP reported. Libya conducted chemical weapons production and storage in facilities at Rabta, Sebha and Tarhunah, according to the Monterey Institute’s Center for Nonproliferation Studies.

Libya in 2004 declared possession of 23 tons of mustard gas, one deactivated production facility and two chemical weapons storage sites. It also has more than 1,300 tons of chemical precursors.

“There’s a good chance” that eliminating the chemical agent and related materials would cost more than $100 million, Flory told a Senate panel. “And in that case we have to consider what are the opportunity costs of doing that particular bit of work compared to other, similar work in the former Soviet Union, in Central Asia or other regions.”

Support from the United States could include financial assistance or technical expertise, AP reported.

“Such assistance would reinforce the wisdom of Libya’s decision to eliminate its WMD programs,” the Pentagon said in a statement issued after Tegnelia spoke.

Tegnelia indicated the decision would need to be made carefully, noting that the money could be directed toward U.S. efforts to secure nuclear material in Russia (see GSN, March 30).

“In the end, meeting the Chemical Weapons Convention responsibility is the Libyan government’s responsibility,” he said. “In today’s world, it’s not like they don’t have resources to be able to do that.”

“What are the Libyans prepared to do to help? What is the condition of their (chemical) weapons systems? I mean, if they aren’t a terrorist threat, that would have a bearing on how important it is to try to secure it” (Robert Burns, Associated Press/ABC News, March 31).

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