Regardless of human endeavors, nature’s on-going experiments with H5N1 influenza in Asia and H7N7 in Europe may be the greatest bioterror threat of all.232
On 3 December 2004, U.S. Secretary of Health and Human Services (HHS) Tommy Thompson held a press conference to announce his resignation. His turbulent, heavy-handed reign had alienated most of the leading disease researchers at the National Institutes of Health (NIH) and elsewhere. “I don’t think,” one senior scientist told Nature, “you’re going to find very many people at the NIH who are doing anything but jumping for joy.”233 Yet his tenure ended with a note of frankness rare in the Bush era. Unlike the previous seven cabinet members purged in the President Bush’s postelection housecleaning, Thompson, according to the New York Times, “gave candid, unexpected answers to questions posed to him.” He complained, for instance, that Congress, ever solicitous of the pharmaceutical industry, had refused to give him authority to negotiate lower prices for Medicare prescriptions. He also agreed with FDA critics that an independent watchdog of the agency was needed in the wake of scandals about the safety of Vioxx and other drugs. “Asked what worried him most, Mr. Thompson cited the threat of a human flu pandemic. . . . ‘This is a really huge bomb that could adversely impact on the health of the world,’ killing 30 million to 70 million people, he said.”234
The secretary, of course, spoke with the authority of someone with access to the best medical intelligence in the world, but reporters were undoubtedly surprised that Thompson was so alarmed about a peril that his department with its $543 billion annual budget—a quarter of the federal total—had done so little to address. In the last fiscal year, for example, Thompson had allocated more funds to “abstinence education” than to the development of an avian influenza vaccine that might save millions of lives.235 This is but one example of the way that all Americans, but especially children, the elderly, and the uninsured, have been placed in harm’s way by the Bush regime’s bizarre skewing of public-health priorities. On Thompson’s watch, HHS and the Pentagon spent $14.5 billion to safeguard national security against largely hypothetical biological threats like smallpox and anthrax, even as they pursued a penny-pinching strategy to deal with the most dangerous and likely “bioterrorist”: avian influenza. The administration’s lackadaisical response to the pandemic threat (despite Secretary Thompson’s personal anxiety) is only the tip of the iceberg. Over the last generation, writes Lancet editor Richard Horton, “The U.S. public-health system has been slowly and quietly falling apart.”236
Under Democrats as well as Republicans, Washington has looked the other way as local health departments have lost funding and crucial hospital surge capacity has been eroded in the wake of the HMO revolution. (A sobering 2004 Government Accounting Office [GAO] report confirmed that “no state is fully prepared to respond to a major public-health threat.”)237 The federal government also has refused to address the growing lack of new vaccines and antibiotics caused by the pharmaceutical industry’s withdrawal from sectors judged to be insufficiently profitable; moreover, revolutionary breakthroughs in vaccine design and manufacturing technology have languished due to lack of sponsorship by either the government or the drug industry.
As discussed in an earlier chapter, the so-called “fiasco” of the swine flu vaccine in 1977 was used as an excuse by the Reagan administration to discard the Carter–Califano policy of gradually widening the scope of annual influenza vaccinations. Reagan-era medical priorities were cancer and heart disease—“middle-class” health issues with broad electoral resonance—rather than infectious disease or community-based medicine; as a consequence, savage federal cutbacks in the early 1980s led the Institute of Medicine to warn in 1987 that the United States was ill-prepared to face the threat of emergent diseases. The Institute declared: “The decline in preparedness and effectiveness of the nation’s first-line medical defense systems can be traced to these ill advised budget cuts which forced the termination of essential and research and training programs.”238 A year later, with AIDS raging in big American cities and infectious disease mortality increasing by nearly 5 percent annually, Institute authors added, “We have let down our public health guard as a nation and the health of the public is unnecessarily threatened as a result.” Yet another Institute of Medicine report in 1992, authored by Joshua Lederberg and Robert Shope, contrasted the breakdown of the public-health infrastructure with the radical changes in disease ecology being wrought by globalization.239
There was great hope that the Clinton administration with its strategic focus on health-care reform would finally re-arm the country to adequately face the new viral perils, but as writer Greg Behrman recounts in his bitter history of how Washington “slept through the global AIDS pandemic,” Clinton public-health policy was undermined by the administration’s own fetishism of deficit reduction, followed by the Republican capture of Congress in 1994.240 To her credit, Donna Shalala, Clinton’s HHS secretary, did establish a pandemic influenza planning process in 1993, with the National Vaccine Program Office (NVPO) as the lead agency. After the 1997 Hong Kong outbreak, to which the CDC was a major responder, Shalala ordered NVPO to prepare technical content for a federal response plan; HHS also established a liaison committee on pandemic influenza with the Department of Defense, the Federal Emergency Management Agency (FEMA), and the Red Cross. Much of this, however, was simply bureaucratic rewiring that provided little incentive for vaccine development or re-investment in local public-health agencies.
In October 2000, the GAO scolded HHS for making so little progress in the development of an avian flu vaccine. It warned that the United States might only have a month (or less) of warning before a pandemic became widespread, and it accused HHS of failing to develop contingency plans to ensure expanded vaccine manufacturing capacity. It also pointed to a major contradiction in business-as-usual reliance on the private sector: “Because no market exists for vaccine after [flu season], manufacturers switch their capacity to other uses between about mid-August and December.” At minimum, HHS needed to find some way to keep production lines running full-time, all year long, as well as to diversify the number of companies committed to vaccine production. In addition, the GAO slammed HHS for dithering over whether or not to stockpile antivirals, even as top influenza experts were begging the government to procure as much oseltamivir (Tamiflu)—the “miracle” neuraminidase inhibitor—as possible. Finally, the audit faulted Shalala’s department for poor coordination of the respective roles of the federal government, state agencies, and private manufacturers. Almost eight years of “process,” the GAO report implied, had failed to achieve a “plan” in any substantive or meaningful sense.241
Meanwhile, the Republican leadership in Congress, after driving a silver stake through Clinton’s health insurance reform, slashed at programs that even faintly smacked of social entitlement. Federal funding for state immunization programs (which Clinton had dramatically increased) was a principal target, with aid cut in some cases by more than 50 percent. As a 2000 study by the National Institutes of Health (NIH) emphasized, influenza vaccination already lagged far behind its potential to prevent disease and death. NIH pointed to glaring racial and income disparities in flu vaccine coverage, attributing the low vaccination rates among blacks (22 percent), Latinos (19 percent), and the uninsured (14 percent) to federal cutbacks as well as the increased dependence of Americans upon tightwad HMOs for their medical care.242 Another study by researchers at the University of Rochester found that only 39 percent of black people over age sixty-five received influenza vaccinations as compared with 71 percent of white seniors.243 There was—and is—still a color line in prevention of flu mortality.
As the GAO constantly reminded Congress, the U.S. hospital system could no longer deal with pandemics or mass casualties of any kind. The restructuring of health care around HMOs, with the attendant closure of hundreds of hospitals across the United States, had left many big cities without the capacity to deal with abnormal spikes in patient loads; the HMO ideal was to ruthlessly reduce the number of unused, and thus unprofitable, hospital beds to zero: an example of “just-in-time” management gone berserk. Public hospitals, meanwhile, were caught between their chronic budgetary problems and soaring demand by the more than 40 million poor and uninsured Americans. A 2003 survey by the American College of Emergency Physicians found that 90 percent of the country’s 4,000 emergency departments were seriously understaffed and overcrowded, with little surge capacity.244
Influenza experts point to the ominous experience of Los Angeles during the H3N2/Sidney epidemic in the winter of 1997/98 as a precursor to things to come. Having lost 17 percent of their beds since 1990, Los Angeles County hospitals were overwhelmed by an unexpected influx of flu patients, hardly reassuring evidence of the system’s capacity to deal with a real pandemic crisis.245 After the 2002 election the Institute of Medicine looked back glumly at the Bush senior and Clinton epochs. It found that many of its past recommendations had never been implemented and that the public-health system “that was in disarray in 1988 remains in disarray today.”246
This “disarray,” including all the flaws in HHS’s influenza program (particularly the lack of an antiviral stockpile and adequate vaccine manufacturing capacity), was inherited by Tommy Thompson, the former governor of Wisconsin, described as a “pragmatic conservative” by his friend Ted Kennedy. The Clinton administration’s handling of public-health issues had certainly been disappointing, but the new Bush administration was frightening to everyone who had been fighting to prevent the total meltdown of urban public health. Then, in September 2001, a new dispensation suddenly arrived in the form of poisoned letters contaminated with “weaponized” anthrax. DNA sequencing would later reveal that the anthrax strain used in the attacks almost certainly originated from the Army’s own laboratory at Fort Detrick, Maryland, yet this probable “inside job” became the principal justification for national hysteria about the threat of “bioterrorism” supposedly posed by Iraq, al-Qaeda, and other alien enemies of the United States.247
With shockingly little debate and without any real evidence that such a threat even existed, most public-health advocacy groups, as well as such leading Democrats as John Edwards and Ted Kennedy, became ardent shareholders in the bioterrorism myth. Even the liberal Trust for America’s Health glibly talked of an “Age of Bioterrorism” as if malevolent hands were already opening little vials of botulism and Ebola on Main Street. In fact, the irresistible attraction of the so-called “health/security nexus” was the billions that the White House was proposing to spend on Project BioShield, Bush’s “major research and production effort to guard our people against bioterrorism.” Many well-meaning people undoubtedly reasoned that, however farfetched the excuse, the Republicans were finally throwing money in a worthwhile direction and that some of the windfall would surely find its way to real needs after decades of neglect. Because the defensive preparations against bioterrorism borrowed heavily from pandemic planning, there was hope that influenza (previously shortchanged in the design of the National Pharmaceutical Stockpile in 1999) would be accorded its proper rank as a “most wanted” bioterrorist.
Certainly the leading influenza researchers, from 2001 onwards, were doing their utmost to alert medical colleagues worldwide to the urgent threat of avian flu, as well as outlining the immediate steps that the Bush administration and other governments needed to take. As befitted his position as “pope” of influenza researchers, Robert Webster tirelessly preached the same sermon: “If a pandemic happened today, hospital facilities would be overwhelmed and understaffed because many medical personnel would be afflicted with the disease [the lesson of SARS]. Vaccine production would be slow because many drug-company employees would also be victims. Critical community services would be immobilized. Reserves of existing vaccines, M2 inhibitors, and NA inhibitors would be quickly depleted, leaving most people vulnerable to infection.”248
Webster stressed the particular urgency of increasing production of the neuraminidase (NA) inhibitor oseltamivir (Tamiflu).* Because a vaccine was unlikely to be available in the early stages of a pandemic, Webster urged that “NA inhibitors [e.g. oseltamivir] should be stockpiled now, in huge quantities.” Because this strategic antiviral was “in woefully short supply”—made by Roche at a single factory in Switzerland—Webster and his colleagues underlined the need for resolute government action. “The cost of making the drugs, as opposed to the price the pharmaceutical companies charge consumers, would not be exorbitant. Such expenditure by governments would be a very worthwhile investment in the defence against this debilitating and often deadly virus.” Failure to act would mean intense competition over the small inventory of life-saving Tamiflu. “Who should get these drugs? Health-care workers and those in essential services, obviously, but who would identify these? There would not be nearly enough for those who needed them in the developed world, let alone the rest of the world’s population.”249
Webster was not calling for a new Manhattan Project, just prudent action to ensure an adequate antiviral stockpile. But for almost three years he and other influenza experts were ignored, as were those who argued more generally that “the best way to manage bioterrorism is to improve the management of existing public health threats.”250 The Bush administration instead fast-tracked vaccination programs for smallpox and anthrax, based on fanciful scenarios that might have embarrassed Tom Clancy. In reality, Project BioShield was designed to build support for the invasion of Iraq by sowing the baseless fear that Saddam Hussein might use bioweapons against the United States.* In any event, Washington spent $1 billion expanding a smallpox vaccine stockpile that some experts claim was already quite sufficient. Hundreds of thousands of GIs were forced to undergo the vaccinations, but frontline health workers—the second tier of the smallpox campaign—largely boycotted the administration’s attempts to cajole “voluntary” participation.
In spite of this fiasco and millions of doses of unused vaccine, the administration pressed ahead with the development of second-generation smallpox and anthrax vaccines, as well as vaccines for such exotic plagues as Ebola fever; it continued to reject the “all hazards” strategy recommended by most public-health experts in favor of a so-called “siloed approach” that focused on a shortlist of possible bioweapons. In testimony before the House of Representatives, Tommy Thompson explained that while “private investment should drive the development of most medical products,” only the government was in a position to develop those products that “everyone hopes . . . will never be needed” as a protection against “rare yet deadly threats.” The government, in other words, was willing to spend lots of money on biological threats that were unlikely or far-fetched, but not on antivirals or new antibiotics for the diseases that were actually most menacing. As Project BioShield morphed into the biggest show in town (growing from $3 billion in fiscal 2002 to more than $5 billion in fiscal 2004), Thompson’s wayward logic soon had perverse impacts that confounded the hopes of the biodefense boom’s early enthusiasts.251
For example, instead of spurring a welcome trickle-down of money for research on big killers like influenza, malaria, and tuberculosis, BioShield stole top laboratory talent away from major disease research. With the National Institutes of Health’s research budget barely keeping pace with inflation (after its banquet days under Clinton), there was an irresistible tropism of researchers and research projects toward biodefense windfalls. Reporting on this new “brain drain,” writer Merrill Goozner cited the case of a leading UCLA lab that phased out its “basic science research on TB in favor of studying tularemia [rabbit fever]”—a disease that “has zero public-health importance”—because the latter infection was “on the government’s A-list of potential bioterrorism agents” and tuberculosis was not.252 (After workers at a different lab accidentally infected themselves with tularemia, some scientists expressed concern to the New York Times that “leaky” biodefense research “may pose a menace to public health comparable to the still uncertain threat from bioterrorism.”)253
To many infectious disease experts, Project BioShield was Bush’s and Thompson’s version of Through the Looking Glass, with priorities established in inverse relationship to actual probabilities of attack or outbreak. “It’s too bad that Saddam Hussein’s not behind influenza,” complained Dr. Paul Offitt, a dissident member of the government’s advisory panel on vaccination. “We’d be doing a better job.”254 Indeed, HHS’s zeal to combat hypothetical bioterrorism contrasted with its incredible negligence in exercising oversight over the nation’s “fragile” influenza vaccine supply. As the GAO had warned Donna Shalala, vaccine availability in a pandemic would depend upon the stability and surge capacity of existing production lines. But as shocked Americans discovered in the winter of 2003–4 and again in early fall 2004, the entire vaccine manufacturing system had decayed almost to the point of collapse. While Bush and Thompson were trying to bribe the pharmaceutical industry to join Project BioShield, the same industry was abdicating its elementary responsibility to maintain a lifeline of new vaccines and antibiotics.
“Big Pharma,” as recent exposés have emphasized, is the most profitable industry in the United States, and it maintains the most powerful lobby on Capitol Hill. (According to Harvard Medical School’s Marcia Angell, the ten big drug companies included in the Fortune 500 in 2002 earned more in profit than all the other 490 corporations combined.)255 Thanks to the tolerance of a Congress awash in its campaign contributions, the drug industry mines gold from outrageous prescription prices for drugs that manage chronic illness (diabetes, high blood pressure, asthma, and so on), as well as the sale of such lifestyle enhancers as Viagra.
Products that actually cure or prevent disease, like vaccines and antibiotics, are less profitable, so infectious disease has largely become an orphan market. As industry analysts point out, worldwide sales for all vaccines produce less revenue than Pfizer’s income from a single anticholesterol medication.256 Despite the 90,000 Americans who die every year from hospital infections, the drug corporations also scorn spending money on the development of new antibiotics. Indeed, as Nature writer Martin Leeb points out, “from a marketing standpoint, antibiotics are the worst sort of pharmaceutical because they cure the disease.”257 The giants prefer to invest in marketing rather than research, in rebranded old products rather than new ones, and in treatment rather than prevention, in fact, they currently spend 27 percent of their revenue on marketing and only 11 percent on research. (Not surprisingly, “all the CEOs of major pharmaceutical companies [are] from marketing and sales; they are not scientists.”)258 “Preventing a flu epidemic that could kill thousands,” wrote Donald Barlett and James Steele in Time magazine, “is not nearly as profitable as making pills for something like erectile dysfunction.”259
* The other neuraminidase inhibitor, zanamivir (Relenza), is equally effective, but it is an inhaled drug in short supply, not as attractive a candidate for stockpiling as the much easier-to-use Tamiflu.
* By militarizing the biotechnology sector, BioShield also obviously aims to woo young science entrepreneurs and their startup firms to the Republican Party.