Lawrence O. Gostin on Biosecurity Policy: Are We Safer Today?
Professor, Georgetown University and Johns Hopkins University; Visiting Professor, Oxford University
Spurred by 9/11 and the anthrax attacks, biosecurity has become an important issue, with the government pouring billions of dollars into biosecurity preparedness and entirely reorganizing public health and emergency services through the Department of Homeland Security (DHS). In this commentary, Professor Lawrence O. Gostin discusses biosecurity legislation and disease-specific plans. He also addresses the Model State Emergency Health Powers Act and related civil liberties questions. He writes:
The biotechnology industry has not systematically developed countermeasures for emerging infectious diseases and bioterror agents because the market is speculative. As a result, industry has focused on products of commercial value. According to the Institute of Medicine, vaccine development has been poorly organized, planned, and funded, putting the nation at risk. To encourage companies to develop new biodefense countermeasures, Congress enacted Project BioShield Act of 2004, which establishes a Special Reserve Fund of $5.6 billion over ten years to purchase medical countermeasures against a broad array of chemical, biological, radiological, and nuclear agents. BioShield also authorizes the Food and Drug Administration (FDA) to permit rapid distribution of promising yet unapproved and unlicensed new drugs and antidotes in emergencies.
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Until the FDA approved the anthrax vaccine absorbed (AVA) in December 2003, there was no approved anthrax vaccine. Nonetheless, in 1998 the Department of Defense (DoD) established the Anthrax Vaccine Immunization Program (AVIP), designed to achieve total force protection against anthrax by 2004. The military is concerned about battlefield safety, but the AVIP remains highly controversial. The evidence for the safety and effectiveness of the anthrax vaccine is equivocal. Members of the armed forces are concerned about possible adverse effects in the short and long term, and they question the DoDs decision to compel soldiers to be vaccinated against their will. In 2003, members of the armed forces successfully challenged the AVIP in Doe v. Rumsfeld. Days after the court halted the program, the FDA published a final rule categorizing the vaccine as safe and effective for use against inhalation anthrax. In doing so, however, the FDA violated its own rules requiring time for meaningful public comment, so the judiciary halted the program again in October 2004. For the next two years, the program proceeded under a voluntary protocol and participation rates did not exceed 50%. After the FDA issued a proper formal rule finding the vaccine safe and effective, the DoD announced on October 15, 2006, that it would resume mandatory anthrax vaccinations.
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Real reform would have the following elements: (1) build capacity in the health system (public health and health care) to meet everyday health needs of the population; (2) ensure surge capacity in the event of a health emergency; (3) plan for just allocation of services under conditions of shortage; (4) develop a broad capability for a wide range of medical countermeasures (vaccines and pharmaceuticals); and (5) plan for the use of traditional public health strategies to reduce risk to the population. These measures may lack the glamour or political allure of planning to rescue the country from a few frightening diseases, but what they lack in glamour they gain in effectiveness because they deal with the most common and likely causes of illness and death in the population.
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In the midst of the anthrax attacks in 2001, the CDC asked the Centers for Law and the Publics Health at Georgetown and Johns Hopkins Universities to draft what became known as the Model State Emergency Health Powers Act (MSEHPA). It addresses five key public health functions discussed in this Commentary: preparedness and planning, surveillance, management of property, protection of persons, and communication and public information. The MSEHPA is designed to standardize and clearly delineate the powers states have when responding to public health emergencies. It was also drafted in recognition of the fact that most public health statutes pre-dated modern judicial conceptions of individual rights, so it provides clearer standards and stronger guarantees of due process.
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