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March 6, 2008
Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program
Summary
The U.S. is in a race to prepare for the mass production of a vaccine before the next influenza pandemic strikes. In a pandemic, there could be deaths in the hundreds of thousands in the U.S. and in the tens of millions worldwide. A vaccine will limit the harm caused by the influenza virus when it appears and spreads. Yet the current government plan for production of the vaccine for pandemic flu does not reflect the urgency of the problem nor the critical leadership it deserves. In addition, a lack of sufficient disclosure has beset the program to date.
Types of Information to Disclose
The following documents and information should be disclosed to the public in a conveniently accessible fashion, such as on the government's pandemic flu website. At present, much of this material is not available or is available only partially on government websites. Some of the documents referenced below are required by law to be provided through Freedom of Information Act requests, but are in fact either unavailable or are provided only after a long delay.
(1) Government contracts for vaccine production. The full text of these multi-million dollar contracts should be published online. There are precedents for this. The U.S. Agency for International Development (USAID), for instance, occasionally posts its contracts online.12 In contrast, HHS has issued only short summaries and press releases on contracts in the flu vaccine program;13 the contracts themselves are not available for examination online. Public scrutiny of the contracts has become more important in light of the failure by one company (in the bioterrorism program) to meet its contract requirements, resulting in the cancellation of an $877 million contract with that company and a major setback to the government's efforts to obtain anthrax vaccine.14 In addition to the contracts themselves, there should be online publication of progress reports covering the contracts and evaluations of contractors' performance, updated periodically. It is important that those writing the progress reports and performance evaluations be identified, particularly their government or non-government affiliations and possible conflicts of interest.
(2) Manufacturing capacity. The status of the nation's flu vaccine manufacturing capacity, the plans for expanding this capacity, and estimates of the capacity in the future are obviously important, because expanded capacity before a pandemic translates into speedier production during a pandemic.15 Much of this information has already been published online at www.pandemicflu.gov. However, the success of the government's vaccine program depends on adequate manufacturing capacity. For this reason, further details should be provided on the federal government's specific plans for the expansion of manufacturing capacity. The government should consider further expansion of manufacturing capacity through government subsidies or price guarantees. It is very costly to create new manufacturing plants purely as standby facilities, idle until the outbreak of a pandemic. An alternative is dual-purpose plants used regularly for the production of seasonal flu vaccine; these plants are profitable for the manufacturer and are also available immediately to produce pandemic flu vaccine when needed. The construction of such manufacturing plants can be encouraged by government subsidy of annual flu shots, and Ontario, Canada, has just such a program. Although the U.S. government is aware of this program, there are apparently no plans to adopt it, a decision that should be justified publicly.16
(3) Domestic dependence on foreign production. After the start of a pandemic, manufacturers in a country will devote their full production capabilities to production of vaccine f
or the domestic use within that country. Foreign sources of materials for vaccine production (and steps that are part of vaccine production) that were available under non-pandemic conditions may be blocked once a pandemic starts. In the fall of 2004, shortly before the beginning of the flu season, half of the total U.S. supply of vaccine for seasonal flu was interrupted.17 The reason: a manufacturer in England, Chiron Corporation, had discovered a technical problem (bacterial contamination) that rendered its vaccine unusable. Partly as a result of this experience, the manufacturing facilities for pandemic flu vaccine are now located in the U.S. However, the manufacturers may currently be dependent on foreign sources for some materials or steps in the manufacturing process. Any such dependence on foreign sources, as well as the timetable for full self-sufficiency, should be described online.
(4) Material transfer agreements. Statements should be published online about the status of the government's efforts to facilitate transfer of materials (such as virus samples, antibodies, and cell lines) from one research group or company to another, including a discussion of cases in which this process is not working well. For example, when efforts to enter into material transfer agreements related to the vaccine program are hindered or delayed, as much information as possible should be made public. In cases like these, as in others involving the protection of intellectual property, the business practices that are customary in ordinary circumstances may be detrimental to public health and safety in an emergency.
(5) Intellectual property. Guidelines and statements should be published online about access to intellectual property (patents, trade secrets, and know-how), including a description of the government's efforts to broaden access through discussion, negotiation, and subsidies; the initial steps of compulsory licensing; and completion of compulsory licensing. If there are specific cases in which this process is not working well, they should be discussed publicly to the extent possible. In addition, specific plans, if any, should be outlined for head-to-head clinical comparisons of the few most promising vaccines containing patented, proprietary adjuvants and/or aluminum salt adjuvants. More generally, the timetable of plans, if any, to start discussions of compulsory licensing with patent owners (or if necessary, to impose compulsory licensing) should be described and explained online. If, as seems likely, the government's current plan is to postpone any compulsory licensing until the start of a pandemic, reasons should be given for this decision. In that case, it is important to include an assessment of the risks of postponement. [See Appendix B for more information on patent rights.]
(6) Foreign governments and the World Health Organization. The U.S., among all countries, has made the largest monetary contribution to global efforts to prepare for a pandemic.18 The U.S. government is issuing reports on its plans for coordinating its vaccine program with that of foreign governments and the WHO.19 These public reports should be expanded to include an explicit statement of what the U.S. government will and will not do for other countries when a pandemic begins.
(7) Alternatives to current vaccines. Major increases in government support for the production of other kinds of vaccines, such as live-attenuated vaccines20 and recombinant hemagglutinin vaccines,21 should be considered and discussed online. Administrators and scientists in the government's vaccine program are undoubtedly well aware of arguments for and against investing more heavily in the production of these types of vaccine. Live-attenuated and recombinant hemagglutinin vaccines lend themselves to rapid, large-scale production and the immunization of large populations22?a significant advantage if a pandemic should emerge within the next few years. The expertise and most of the facilities needed to produce these vaccines already exist. With the available resources and with adequate funding, billions of doses of vaccine could be produced significantly faster than six months after the start of a pandemic.23 In recent congressional testimony, a senior HHS official stated that a contract solicitation was issued in August 2007 for development of recombinant vaccines over the next three to five years.24 There should be a public explanation of the need for this long a period. The U.S could make a noteworthy and honorable contribution to world health by speeding up the timetable for flu vaccine availability around the world.
(8) Size of budget. Questions about the total federal budget for pandemic flu preparedness were raised in a 2006 Journal of Infectious Diseases article entitled, "Seasonal and pandemic influenza: Recommendations for preparedness in the United States."25 The article contains recommendations made by representatives from the federal government, state and local governments, professional societies, academia, and the pharmaceutical industry. The authors of the article propose a several-fold increase in the level of funding?namely, an additional $30 billion?for pandemic preparedness.26 They propose that part of this amount be used to expedite vaccine development, expand domestic vaccine production sources, and increase seasonal vaccination. The arguments for and against their proposal should be discussed by federal employees on the government's pandemic flu website for consideration by non-government experts and the general public. Changes in current plans for vaccine production may require a significant increase in the total budget of the vaccine program. However, the trend of congressional appropriations may be in the opposite direction.27
The Project On Government Oversight (POGO) follows a rich tradition of assuring that the government continues to work for the people it represents. Our nation was founded on the very principle that representation and accountability are fundamental to maintaining a strong and functioning democracy. Today, these principles espoused by our founding fathers are under attack as our federal government is more vulnerable than ever to the influence of money in politics and powerful special interests.