Before leaving for a two-week Thanksgiving recess, Congress took several steps forward and one step back on the 2006 budget. Congress finalized and quickly agreed to conference reports for bills containing the DOT and VA budgets. Conferees also agreed on a Labor-HHS conference report that would make cuts in education and health programs and would provide less than a 1 percent increase for NIH, but the full House rejected the conference report by a vote of 209-224. It is unclear what will happen next: Congress could renegotiate the conference report, attach the current report to the Defense conference report, or fund programs with a year-long continuing resolution.

Congress also approved a 2nd continuing resolution through December 17 to allow more time to complete the two remaining appropriations bills for DOD and NIH. The President signed the Foreign Operations and Energy/Water bills into law last week.

A full summary of recent appropriations actions is available in the updated Status of FY 2006 Appropriations page on the web site. The December S&T newsletter will detail the final appropriations bills.

On November 1, before a packed auditorium on the campus of the National Institutes of Health (NIH), President George Bush laid out a multi-year plan to address the growing global threat of an avian flu pandemic. With an initial investment of $7.1 billion in emergency spending in fiscal year 2006, the White House strategy would be to address three critical goals: detection, protection, and response.

The President stated, “First, 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 price tag 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 outbreaks, minimizing its ability to spread globally.

The plan also includes $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 to reduce the effect of a flu on an infected person; and $644 million for local government response.

An additional $2.8 billion investment would accelerate development of cell-culture technology to allow manufacturers to move away from the current egg-based technique for creating flu vaccines [see box below] and $800 million would go towards research and development of other novel treatments. These strategies could help reach the goal of creating 300 million vaccines within 6 months of a pandemic outbreak; enough to inoculate every American. In testimony before the House Labor-HHS Appropriations Subcommittee and the Energy and Commerce Committee, HHS Secretary Michael Leavitt stated that the experimental vaccine to H5N1 must be given in 2 doses in order to be effective. He estimates that by 2009, the United States would be able to produce approximately 40 million doses using existing production techniques, enough for 20 million individuals.

This pre-pandemic vaccine would be used to immunize healthcare workers and other first responders, however, he emphasized that H5N1 will have mutated by the time it has jumped to human-human transmission making today’s vaccine less effective. With the current egg-based 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; a fraction of the targeted goal of 300 million.

Dr. Tony Fauci, director of the NIH National Institutes of Allergies and Infectious Diseases, emphasized at the hearings that investment in cell-based technologies would allow our nation to develop a “surge-capacity” in producing 80 percent of the targeted goal of 300 million vaccines within 6 months of a pandemic outbreak.

The high price tag of the long-awaited plan along with the uncertainty of how imminent an influenza pandemic truly is resulted in an atmosphere of resistance on Capitol Hill.

While acknowledging the importance of addressing an avian flu pandemic, House Energy and Commerce Committee Chairman Joe Barton (R-TX) stated in his opening remarks 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 an adverse reaction to a vaccine. As Rep. Dave Weldon (R-FL) pointed out, seeking policies to encourage industry participation is important, but the government must also search for policies that encourage patients to submit to a vaccine that may carry unknown risk.

This hesitant reception comes at a time when Congress is still attempting to complete work on its remaining appropriation bills, addressing the immediate demands of funding the war in Iraq, and financing the emergency response to this summer’s hurricanes.

The Department of Defense (DOD) appropriations bill is one of those remaining bills to contend with and it now looks as thought its completion will get pushed into December. Speculation has already begun that the DOD bill will become a ‘mini’ omnibus bill and turn into a vehicle for carrying Administration priorities such as the pandemic flu plan.

Vaccine Production: Egg-Based vs. Cell-Culture

Egg-Based:	For decades, flu vaccines have been cultivated and incubated in fertilized chicken eggs. This requires access to hundreds of millions of eggs retrieved from chickens that have been specially grown and ordered in advance. The total production time takes 6 months, since the virus strain first must be adapted to grow in the eggs. Furthermore, growing chickens and producing eggs cannot be done in a completely closed environment, therefore there is the potential for chickens to be exposed to other diseases. Despite the disadvantages, this method has been utilized over the years because it is relatively inexpensive and, thus, preferable given the uncertain commercial market demand for flu vaccines in any given year.

Cell Culture:	This technology involves growing the virus strain on human, canine, or monkey cells, known as a cell culture, which are grown in a laboratory in large batches. The cell-culture can be manufactured in advance and frozen until it is needed and does not require that a virus strain be adapted before developing the vaccine. Thus, once a virus strain has been identified the manufacturing of the vaccine can begin in less time than egg-based methods and grown more quickly (estimated at 4 months). Additionally, cell-cultures can be grown in the closed and cleaner environment of a laboratory, which reduces the risk of contamination. This is a more expensive process, but scientists believe it is preferable in the face of a pandemic.

Any hopes for a Senate vote on the Stem Cell Research Enhancement Act (S. 471) during the first session of the 109th Congress were dashed when Senate Majority Leader Bill Frist (R-TN) and Sen. Arlen Specter (R-PA) struck a deal to give the bill high priority next year. It was only through a threat to attach S.471 to the chamber’s Labor-HHS appropriations bill that Sen. Specter exacted the Frist agreement.

With the Senate preoccupied with finalizing its appropriations bills, budget reconciliation, Supreme Court nominations, and emergency funding for the disasters left in the wakes of the hurricanes, it did not come as a shock to those monitoring the bill that it would be put on the back burner. However, in order 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 to the importance that all avenues of stem cell research—adult, embryonic, and umbilical cord—need to be explored.

Dr. Rudolf Jaenisch, of the Whitehead Institute, provided an overview of his recent method of producing stem cells without destroying embryos. His technique involves utilizing 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.

Opponents of the Stem Cell Research Enhancement Act, which would lift the current ban on federal funding on embryonic stem cells derived before August 2001, are embracing this new scientific development, claiming that it does not raise the same ethical concerns surrounding embryonic stem cell research.

Jaenisch, however, made it very clear during the hearing that his technique has not been scientifically proven, and questions remain about whether the stem cells obtained by this new method are as ‘flexible’ as the products of embryonic stems cells obtained by other methods. Because of these limitations, Jaenisch believes that research using different types of stems cells must still be pursued. He also emphasized that his research is currently funded by the National Institutes of Health, but only because he utilizes mice tissue and not human cells.

Dr. Judith Gasson, professor of Medicine and Biology at the University of California, stated that she believes that the current policy is slowing 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, Dr. Gasson hopes to find insights into the pathology of cancer cells and mechanisms that inhibit the renewing process.

The frustration behind the limited access to federally funded stem cells lines was echoed by Dr. John Wagner, a clinical researcher at the University of Minnesota that specializes in blood and bone marrow transplants. Wagner stated that while “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.

Furthermore, he emphasized that “[e]very discovery with [embryonic stem] cells has furthered our work with stem cells from umbilical cord blood or adult tissues.”

Finally, Dr. 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. Mr. Chairman, 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.”

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

On November 9, the House Science Committee defeated a Resolution of Inquiry (H. Res. 515) by Rep. Dennis Kucinich (D-OH) that would have required the Administration to turn over all documents produced by executive agencies related to the impact of climate change on coastal regions. A Resolution of Inquiry is a rarely-used House procedure to obtain documents from the Executive Branch. Under House rules, the resolution is referred to committee, where action must be taken within 14 legislative days or the sponsor can introduce it as a privileged motion on the House floor.

Kucinich cited the devastation from recent hurricanes as a factor in introducing the resolution, which had 150 cosponsors, all Democrats.

Science Committee Chairman Sherwood Boehlert (R-NY) began the markup by noting that the vote is not “a barometer of what the House thinks, or is willing to do about, global climate change. Personally, I support mandatory caps on carbon dioxide, and I think there is growing concern about climate change around the country.”

He stated that information on the potential impact of climate change on U.S. coasts is the subject of countless scientific papers that are readily available. He also questioned the difficulty of receiving information from the Administration, asking, "So what prompted this? Has anyone sought specific documents for specific reasons under standard procedures and been denied? Not that we know of.”

Ranking Member Bart Gordon (D-TN) stated that the Administration has not shared information with Congress and the public and he supports the resolution, as it would send a message to the Administration to provide information in a timely matter.

The resolution was defeated 11 to 16 along party lines and, by voice vote, was reported from Committee adversely. It will not be brought before the full House.

Negotiations on international climate policy will take place in the coming weeks at the 11th Annual United Nations Climate Change Conference in Montreal. This meeting, held from November 26- December 9, will feature both the eleventh session of the Conference of the Parties to the United Nations Framework Convention on Climate Change (COP 11) and the first meeting of the Parties to the Kyoto Protocol (MOP 1) since the Protocol's entry into force.

This intergovernmental event is expected to draw up to 10,000 participants, including delegates from 189 countries, observers from government, industry, business, public interest organizations and the scientific community, and more than 1,000 journalists. The goals of the meeting are to assist implementation of the Kyoto Protocol and to begin negotiations for a climate policy after the Kyoto Protocol ends in 2012.

Though many have expected the United States to resist efforts for post-Kyoto efforts, Senate Foreign Relations Committee Chair Richard Lugar (R-IN) and Ranking Member Joe Biden (D-DE) introduced a Sense of the Senate resolution on November 15 calling for the United States to return to climate negotiations that “establish mitigation commitments by all countries that are major emitters of greenhouse gases, consistent with the principal of common but differentiated responsibilities.”

This statement appears to respond to concerns over the Kyoto Protocol’s lack of inclusion of 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 also establish a Senate Observer Group to “ensure bipartisan Senate support for any new agreement.”

In Montreal, delegates plan to approve 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.

Paula Dobriansky, U.S. Under Secretary for Global Affairs, who leads U.S. climate policy, will lead the U.S. delegation in Montreal.

The topic of innovation and concerns over U.S. competitive stance has continued to garner a great deal of attention, most recently with the release of a National Academies of Science report entitled “Rising Above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future." This latest report, requested by Members of Congress, spurred both a hearing by the House Science Committee and the release of an Innovation Agenda by Democratic leaders.

In his opening remarks at the hearing, House Science Chairman Sherwood Boehlert (R-NY) warned that “complacency will kill us. If the United States rests on its withering laurels in this competitive world, we will witness the slow erosion of our pre-eminence; our security and our standard of living.”

The National Academies report, produced by a committee chaired by Norman Augustine, former CEO of Lockheed Martin, recommends that the United States make changes in four critical areas: K-12 science and math education, higher education, federal research and development (R&D) investment, and private-sector policies.

At the hearing, Dr. Roy Vagelos, former CEO of Merck, stated that improving K-12 science education must be Congress’s first priority if it wishes to strengthen America’s economic future prospects. He outlined the committees suggestions including: recruiting 10,000 new science and math teachers with four-year undergraduate scholarships; providing continuing education programs for current teachers; and encouraging high school students to take advanced placement (AP) and international baccalaureate (IB) science and math classes.

In the area of higher education, it advises using scholarships to increase the number of U.S. citizens studying math and science at the undergraduate and graduate levels, providing a tax credit for continuing education, and making it easier for international scientists and students to obtain visas that allow them to remain in the United States.

Augustine urged a 10% annual increase in federal basic research funding, especially in physical sciences, mathematics, and engineering, arguing that this level of growth has historically been manageable and, if continued for seven years as recommended, will result in a doubling of basic research funding. However, when questioned on how such increases should be offset given the current austere budget environment, Augustine acknowledged that the committee was not tasked to address such a topic.

The report also recommends creating a Defense Advanced Research Projects Agency within the Department of Energy (ARPA-E) to invest in high-risk energy research, a suggestion that was met with skepticism by Rep. Judy Biggert (R-IL). She expressed concern that the government would be in a position of picking ‘winners and losers’ in energy technology. Biggert’s views were also held by one of the committee members and noted in the final report.

Members of the Science Committee strongly urged the committee that developed the Gathering Storm report to advocate for implementing the policies outlined in the report. However, the witnesses demurred, explaining that the National Academies of Science, a semi-governmental organization, cannot lobby Congress.

Nonetheless, Ranking Member Bart Gordon (D-TN) pledged that Democrats will follow through.

Jumping on the innovation bandwagon, Minority Leader Nancy Pelosi (D-CA) held a press conference on November 15 to unveil the House Democrats' "Innovation Agenda." The agenda items are similar to the recommendations of the Augustine report, including scholarships for STEM students, qualified teachers in every math and science classroom, doubled NSF funding, a larger R&D tax credit, intellectual property protections, special visas for international science graduate and postdoctoral students, universally available broadband internet access and an ARPA-E. The House Democrats also propose making the United States energy independent in ten years by developing alternate fuels and new types of vehicles.

Meanwhile, across the Capitol, Senators Joe Lieberman (D-CT) and John Ensign (R-NV) are currently drafting bipartisan legislation to implement a series of policies based on the “National Innovation Initiative” report from the Council on Competitiveness. The legislation, which the senators originally planned to introduce in September, has reportedly been delayed by lack of agreement on its immigration provisions.

Reports and Publications

These reports are currently only available on the NAS website, but hard copies will be available shortly.

"The Assembly of Protocells"
Thursday December 1, 2005

Reception 5:15 PM, Lecture and Discussion 6:00-8:00 PM
AAAS Dialogue on Science, Ethics, and Religion (DoSER)
1200 New York Ave. NW, 2nd floor auditorium, Washington DC

This lecture will discuss efforts to assemble minimal self-replicating nanomachines from nonliving organic and inorganic matter. This research is not concerned about the historical details of the origins of life, but more about how nonliving matter can self-organize into living matter. If this research is successful and it becomes possible to make general self-replicating materials, this will provide the basis for a very powerful technology. The Keynote Speaker is Steen Rasmussen, Ph.D., Los Alamos National Laboratory.

A recent study in Science shows that climate models have been correctly modeling the additional warming effects from water vapor. Soden et al. used satellite observations to find increasing upper tropospheric moisture from 1982 to 2004, which is consistent with model reconstructions for this period. These findings are important because increased water vapor expected with climate change is expected to play a significant role in additional warming.

Soden et al. "The Radiative Signature of Upper Troposphere Moistening " Science, 4 November 2005, Vol. 310, Issue 5749, pp. 841-844, [DOI: 10.1126/science.1115602]

S&T Newsletter: November 2005

Reports and Publications