In his State of the Union message 4 years ago, President Bush announced Project BioShield, which was to acquire vast new stockpiles of vaccines and treatments to counter bioterrorism attacks. Now, the program is still struggling to define its priorities. Only one quarter of the $5.6 billion budget has been spent. A plan concerning what drugs to buy and in what quantities is supposed to be announced in a few months (Washington Post 1/16/07).
The largest program, an effort to produce a safer anthrax vaccine in quantity large enough to immunize the population of Washington and New York, collapsed. The $877 million contract with VaxGen of California, was cancelled in December. There are, however, enough antibiotics to treat 40 million people for 60 days in the national stockpile, which is maintained in 12 secret locations around the country.
The stockpile also contains more than 300 million doses of smallpox vaccine.
Only 15 states, however, are prepared to deliver the drugs or vaccines quickly.
Hundreds of air-sniffing sensors are operating in about 30 metropolitan areas to test for some 20 different microbes and toxins. This program is in a fledgling stage.
Project BioShield is also concerned with radiation threats. The national stockpile contains only enough potassium iodide to treat 1 million people. In February 2006, HHS awarded a contract to Akorn to deliver 390,000 doses of Ca-DTPA and 60,000 doses of Zn-DTPA, intravenous chelating agents to remove plutonium, americium, or curium, as from exposure to a “dirty bomb.” Hollis-Eden Pharmaceuticals is seeking an HHS contract for procurement of Neumune, which it calls “the first practical medical countermeasure that can be forward deployed and administered on a self-administered or out-patient basis in major cities...in the event of a nuclear incident.” At present, there are no therapeutic agents approved to treat acute radiation syndrome (ARS).
Neumune is considered an immune regulating hormone, which is intended to “direct, through controlling gene expression, the production of key cytokines and enzymes.” In rhesus macaques exposed to 400 cGy (rads) of total body radiation, there was a significant decrease in the number of days of severe neutropenia and thrombocytopenia with Neumune therapy. In 80 macaques exposed to 600 cGy of TBI, 12.5% of the Neumune treatment animals died compared to 32.5% of those not treated, in the absence of any clinical support such as antibiotics, intravenous fluids, or transfusions.
In his 2007 SOTU, President Bush did not mention BioShield or other homeland security programs. Presumably, government policy remains the self-help Nuclear War Survival Skills program. The newest “classic” self-help product is the KFM Pak by Stephen Jones, containing the materials needed to build Kearny Fallout Meters: Drywall, doorbell wire, plexiglass, aluminum foil, fishing line, 4-mil vinyl, and the “poor man's NukAlert” card with dimensions (distributed with a previous newsletter). Contact: pccjone1@yahoo.com.
HHS Secretary Michael Leavitt told health officials that “having stockpiles of medication and supplies is essential, but it's distribution that defines victory.” Medications would be closest to the potential user if placed in households. But could Americans handle the responsibility of storing the medications properly and refraining from nonemergency use?
The CDC planned to screen about 20,000 people in the St. Louis area to find 5,000 suitable families to receive a home “MedKit” containing tamper-evident blister-packs of doxycyline or ciprofloxacin. Households were to include families of public health responders, workers at a single corporation, and recipients of care at publicly funded clinics.
The Federal Register notice said that follow-up would monitor for proper drug storage and “explore attitudes, perceptions and other social and psychological factors connected to the drugs.” No data are available on the risks and benefits of home storage, it noted. No study results have been published, as far as we can determine.
In case medications can be found at a time of emergency, the World Health Organization published, in 1986, tests for integrity of some antibiotics. Generally, discoloration or failure to dissolve completely indicates gross degradation. A solution of doxycycline is yellow; oxytetracycline is colorless. Ampicillin should be checked for formation of a hard, yellow mass, and a solution should not form a precipitate when hydrochloric acid is added. The book Basic Tests for Pharmaceutical Substances, which primarily concerns checking for drug counterfeits, is available at amazon.com. Appendix II, on the antibiotic testing, is posted at www.oism.org/ddp/doxytest.pdf .
Passed by unanimous consent, a bill dubbed “BioShield Two” creates a new bureaucracy to oversee research into countermeasures against epidemics and bioterrorism: the Biomedical Advanced Research and Development Agency, BARDA. It provides $1.07 billion to help biotechnology companies through the “Valley of Death”–the time between initial research and ready-to-buy procurement. Controversial features include a provision that exempts BARDA from the Freedom of Information Act to the extent that information could, in the opinion of the Secretary of HHS, reveal vulnerabilities in defenses that are not publicly known. The bill also gives the Secretary the unchallengeable authority to decide whether a manufacturer violated drug safety laws, and absolves manufacturers of all liability for adverse effects of products citizens are ordered to take in a public health emergency.
The history of forced vaccination began with smallpox; there is no stronger public-health rationale for any vaccine. The Compulsory Vaccination Act of 1853 in England required parents to vaccinate every baby before age 3 months or pay a fine of 20 shillings. Outbreaks followed in 1854, 1855, 1856, culminating in the Great outbreak of 1871, with 42,000 deaths, 4 years after a more stringent Act passed. Adverse effects included amputations and the spread of syphilis and leprosy. Resistance to vaccines was not based on superstition or prejudice, but on observations such as those leading to the Royal Commission's recommendation that mandatory vaccination be stopped. A historical timeline on various vaccines and epidemics from 1717 to 2006, prepared by Andrew Maniotis, Ph.D., of the University of Chicago, is available at www.oism.org/ddp.
The 25th annual meeting of DDP will be held at the Hilton Oakland Airport Hotel, beginning with a welcome reception on Friday evening, Aug 3, and adjourning around 5:00 p.m., Sunday, Aug 5. An optional tour, to be announced, is in the planning stage for Friday. You can make your hotel reservations now at (510) 635-5000. The DDP rate is $105. Space is limited, so don't delay!
DDP, 1601 N. Tucson Blvd. Suite 9, Tucson, AZ 85716, (520)325-2680, www.oism.org/ddp