From the Hill – Winter 2006

White House unveils pandemic flu plan

In a November 1 speech at the National Institutes of Health (NIH), President Bush proposed a multiyear plan to address the growing global threat of an avian flu pandemic. The plan includes an initial investment of $7.1 billion in emergency spending in fiscal year 2006, which is provoking some resistance in Congress.

In the speech, the president said his plan is designed to meet three critical objectives. “First,” he said, “we must detect outbreaks that occur anywhere in the world; second, we must protect the American people by stockpiling vaccines and antiviral drugs, and improve our ability to rapidly produce new vaccines against a pandemic strain; and, third, we must be ready to respond at the federal, state and local levels in the event that a pandemic reaches our shores.”

The $7.1 billion emergency spending would include:

• $251 million to assist other countries in training personnel and to develop surveillance and testing systems that will allow for early detection and containment of avian flu outbreaks
• $1.5 billion for the Departments of Health and Human Services (HHS) and Defense to purchase an experimental influenza vaccine based on the current H5N1 strain that is spreading throughout Asia
• $1 billion to stockpile antiviral medications
• $644 million for local government response
• $2.8 billion to accelerate development of cell-culture technology to allow manufacturers to move away from the current egg-based technique for creating flu vaccines
• $800 million for R&D of other novel treatments

The president said he would like to eventually achieve a goal of producing 300 million doses of vaccine within 6 months of a pandemic outbreak.

In testimony before the House Labor-HHS Appropriations Subcommittee and the Energy and Commerce Committee, HHS Secretary Michael Leavitt said that the experimental vaccine for H5N1 must be given in two doses to be effective. He estimates that by 2009, the United States would be able to produce about 40 million doses using existing production techniques, enough for 20 million individuals.

This pre-pandemic vaccine would be used to immunize health care workers and other first responders. However, Leavitt emphasized that H5N1 would have mutated by the time it could be easily transmitted between humans, thus making today’s vaccine less effective. With the current egg-based production techniques, it would take six months from a pandemic outbreak to research, test, and produce 60 million courses of a new vaccine based on the current mutated strain.

Anthony Fauci, director of NIH’s National Institutes of Allergies and Infectious Diseases, said at the hearings that investment in cell-based technologies would allow the United States to develop the “surge capacity” needed to produce 80% of the targeted goal of 300 million vaccine doses within 6 months of a pandemic outbreak.

The high price tag of the new plan and uncertainty about how imminent an influenza pandemic is have lead to some congressional skepticism. Although acknowledging the importance of addressing an avian flu pandemic, House Energy and Commerce Committee Chairman Joe Barton (R-TX) said that, “Wasting taxpayers’ money will not keep people from catching the flu.. . . We need to sort out our real weaknesses from our imagined ones, and determine where the application of money and good sense will actually improve our preparedness and stop the flu.”

Meanwhile, other members of the committees questioned the administration’s plan to give industry liability protection without considering recourse options for patients in the event of adverse reactions to a vaccine. Rep. Dave Weldon (R-FL) said that although ensuring industry participation is important, government policy must also seek to encourage patients to submit to a vaccine that may carry unknown risk.

Senate delays action on bill to ease stem cell research restrictions

A Senate bill that would ease current restrictions on federal funding of embryonic stem cell research has been postponed until 2006. However, consideration of the bill will be given a high priority early in the next session, according to an agreement worked out by Majority Leader Bill Frist (R-TN) and Sen. Arlen Specter (R-PA). Specter had threatened to attach Stem Cell Research Enhancement Act (S. 471) to the Labor-HHS appropriations bill to force consideration of it in 2005.

To keep the issue of stem cell research funding in the public eye and to shore up support for the legislation, Specter held a hearing on the state of the science on October 19. At the hearing, four scientists and a cancer survivor testified about the importance of exploring the potential of every kind of stem cell: adult, embryonic, and umbilical cord.

Rudolf Jaenisch of the Whitehead Institute at MIT described his recently developed method for producing stem cells without destroying embryos. The technique involves using a form of somatic cell nuclear transfer (a cloning method) that switches off a gene in the donor nucleus and essentially makes it incapable of being implanted in a uterus. Groups that oppose current research because embryos must be destroyed have embraced this new development.

Jaenisch, however, made it clear that his technique has not been scientifically proven, and questions remain about whether the stem cells derived from the method are as “flexible” as the products of embryonic stem cells obtained by other methods. Because of these limitations, Jaenisch believes that research using different types of stem cells must still be pursued. He also emphasized that his research is currently funded by NIH only because he uses mouse tissue and not human cells.

Judith Gasson, professor of medicine and biology at the University of California–Los Angeles, said she believes that current policy is slowing the progress of related research breakthroughs by limiting access to healthy human stem cells. By studying the ability of stem cells to self-renew and differentiate, Gasson hopes to find insights into the pathology of cancer cells and mechanisms that inhibit the renewing process.

The frustration engendered among researchers because of the current limited access to stem cells lines was echoed by John Wagner, a clinical researcher at the University of Minnesota who specializes in blood and bone marrow transplants. Wagner said that although “we are excited about the future potential of these stem cells …never have we suggested that they obviate the need for [embryonic stem] cell research. For example, never have the stem cells from cord blood or adult tissues ever produced heart muscle cells that spontaneously beat or formed islets that secrete insulin, as has been shown repeatedly with [embryonic stem] cells.” In addition, he emphasized that “every discovery with [embryonic stem] cells has furthered our work with stem cells from umbilical cord blood or adult tissues.”

Steven Teitelbaum, a professor of pathology and immunology at Washington State University, argued on behalf of all areas of research. “Opponents of human embryonic stem cell research often articulate their position as a contest between adult and embryonic stem cells,” he said. “This is not a contest between various types of stem cells. It is a contest between us as a society and disease. We should be moving forward on all fronts, adult, embryonic, and umbilical cord stem cells, to win the battle. The tool is not important. What counts is curing our neighbors.”

Asked by Appropriations Chairman Thad Cochran whether there was disagreement and controversy about stem cell research in the scientific community, Teitelbaum said he believed that the “overwhelming opinion of scientists is to go forward with stem cell research” and there was “no major disagreement among the scientific community.”

Senators urge U.S. to return to climate change talks

Just before a major international meeting on climate change in Montreal, Senate Foreign Relations Committee Chair Richard Lugar (R-IN) and Ranking Member Joe Biden (D-DE) on November 15 introduced a Sense of the Senate resolution that calls for the United States to return to international negotiations on reducing greenhouse gases that lead to climate change.

The resolution stipulates that any future accord “establish mitigation commitments by all countries that are major emitters of greenhouse gases, consistent with the principle of common but differentiated responsibilities.” The stipulation responds to concerns about the Kyoto Protocol’s lack of inclusion of emission reduction targets for developing countries, particularly China and India, whose emissions may soon exceed those of most developed countries.

The resolution cites scientific consensus that anthropogenic greenhouse gases threaten the stability of the global climate and notes that climate change presents long-term risks to the U.S. economy and has implications for national security. It would establish a Senate Observer Group to “ensure bipartisan Senate support for any new agreement.”

The resolution was proposed just before the 11th Annual United Nations (UN) Climate Change Conference, which was to be held from November 26 to December 9. The meeting was to feature both the 11th session of the Conference of the Parties to the UN Framework Convention on Climate Change and the first meeting of the Parties to the Kyoto Protocol since the Protocol’s entry into force.

Delegates at the meeting were expected to work on mechanisms to strengthen and implement the Kyoto Protocol. These include implementing the Clean Development Mechanism, which allows industrialized countries to receive credits for their investments in emission reduction projects in developing countries, and a Joint Implementation program, which allows developed countries credit for reductions they make in other participating developed countries. Parties also hope to establish an international emissions trading scheme.

Delegates were also planning to begin negotiations on a climate policy to take effect after the Kyoto Protocol expires in 2012.

House votes to revamp Endangered Species Act

The House on September 29 passed a bill that would reduce certain protections for endangered species. The Threatened and Endangered Species Recovery Act was sponsored by Rep. Richard Pombo (R-CA), who, citing statistics that fewer than 1% of species have been recovered under the Endangered Species Act (ESA), declared the act a failure.

Pombo’s bill would repeal the “critical habitat” program that protects lands necessary for species recovery, replacing it with a nonbinding recovery plan. The bill focuses on private property rights, providing funds to compensate landowners for the loss of use of their land due to the presence of endangered species. Provisions stipulate that if the federal government does not determine whether private land development would adversely affect species within 180 days, then development would be automatically approved.

Early versions of the bill eliminated protection for species that fall under the “threatened” status that often precedes an endangered listing, but an amendment by Rep. Mark Udall (D-CO) restored those protections.

The bill requires the secretary of the interior to define “what constitutes the best available scientific data.” The bill also states: “To the extent that data compiled for a decision or action do not: (1) meet the criteria for the best available scientific data; (2) are not in compliance with OMB (Office of Management and Budget) Guidance for compliance with the Data Quality Act; (3) do not include any empirical data; or (4) are found in sources that have not been subject to peer review in a generally acceptable manner, then the Secretary must undertake measures to ensure compliance with the criteria and/or guidance and may secure empirical data, seek appropriate peer review and reconsider the decision or action based on such compliance actions.”

Many in the environmental and scientific community have argued that these provisions weaken the role of science and favor empirical data over statistical models that are often used in wildlife management.

During the floor debate, a coalition led by Reps. George Miller (D-CA) and Sherwood Boehlert (R-NY) offered a substitute amendment to the bill that would keep some of the protections for species that the Pombo bill eliminated. The Miller-Boehlert amendment was defeated by a vote of 206 to 216.

Legislation to revamp the ESA has not been introduced in the Senate, which is waiting for recommendations to be made by a bipartisan group known as the Keystone Commission.

“From the Hill” is prepared by the Center for Science, Technology, and Congress at the American Association for the Advancement of Science (www.aaas.org/spp) in Washington, DC, and is based on articles from the center’s bulletin Science & Technology in Congress.