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Show The Salt Lake Tribune NATION Sunday, October 28, 2901 A5 Federal Blunders Slowed Production of Anthrax Vaccine Evenmilitary safety affected by breakdown in communication BY JOHN HANCHETTE GANNETT NEWS SERVICE WASHINGTON — The nee tagon and other federal agencies have been trying ae spur production of a vaccine for anthrax since Iraq invaded Kuwait 11 years ago. In a time whenthe nation’s capital and muchofthe eastern is reeling from a postal anthrax @ They havefailed to meet their original goal of immunizing all military active-duty personnel. They have failed to develop an anthrax vaccine that easily can be transferred to civilian use. @ They have failed to produce anylicensed vaccineatall during thepast three years. This’ week, the watchdog General Accounting Office explained why. The GAO document describes a decadelong, near-total breakdown of communication between the Pentagon and the Food and Drug Administration, which has yet toapprovea restart of the country’s only anthrax vaccine production line, which the FDA shut down years ago. At the vortex of this criticism is BioPort Corp., a Lansing, Mich., pharmaceutical companystruggling to produce the vaccine after purchasing the facility in 1998 from the state of Michigan — which owned the old plant and had its department of public health run it. The state had come under intense pressure from the Pentagon in late 1990 to produce enough doses for inoculating U.S. troops preparing to kick Iraqiforces out of Kuwait. (The military suspected Iraq of weaponizing anthrax spores, and eventually almost a halfmillion troops were inoculated.) Michigan health officials found that they could increase the speed and volume of their productionline ifthey replaced their ceramicfilters with nylon filters, and if they removed the original glass fermenters and installed stainless-steel vats. “The Michigan facility did not notify FDA of a number of changes made in the manufacturing process in the 1990s,” said GAO inspectors, “and no specific studies were undertaken to confirm that vaccine quality was notaffected.” At one point, the relationship between state scientists and federal examiners reached a bizarre Catch-22 standoff. “The Michigan facility did not notify FDA of changes made in the manufacturing process in the 1990s and no Specific studies were undertaken to confirm that vaccine quality was not affected.” GAO REPORT on the fermenterreplacements, the agency did notreceive supporting documentation until 1999 when BioPort — which: took over the year before — amended its license application. The FDAfinally approved the fermenter changes in May, ,eight years after their installation. The new nylonfilters were even more vexing to the FDA. The GAOsaidit “could find no evidence” the filter changes ever were reported to the FDA, so it contacted the food and drug overseers in December. “They .told us,” wrote the GAOinspectors,“that they had not beennotified and were not aware of changes to anyfilters used to produce anthrax vaccine.” The FDA put pressure on BioPort in February 2001, received documentation in April, and approved the filter changes in July — more than a decade after the equipment change. The FDAsaysit cannot even conduct a quality comparison biochemical analysis of vaccine samples from before and after the fermenter and filtration changes because vaccine Even though the war with Iraq ended in early 1991, the FDA would not inspect the Michigan production line until two years later. “According to FDA,” reads the GAO report, “access was not granted because its inspec- tors had not been vaccinated against anthrax.” In other words, the governmentcould not assure that the vaccine was safe to receive, because its examiners had not received the vaccine, because they did not knowif it was safe. Theinspections the FDA ultimately were able to conduct overtime “found a number of deficiencies,” GAO said, many of which were not corrected. When the FDA conducted an intense inspection in 1998, it found “deficiencies” it said “could compromise the safety and efficacy of any batch orall batches.” Production was suspended, and hasnot resumed. Despite FDA requests in 1993 that the state-run vaccine plant submit key information aDaLLealLOE NynWAy & Perwsian doses from ae the switch changes the strain and potency of the anthrax mi —and that using nylonfilters allows more reactive substances and proteins to get through. As the 1990s wore on, and as the Pentagon received more and more evidence that anthrax was the biowarfare weapon of choice for about a dozen rogue nations, it determined to vaccinate all troops headed for the Middle East and South Korea. Defense officials repeatedly insisted that the vaccine was safe andeffective. Butin the armed forces, the anthrax shots gota nasty reputation as causing damaging side effects like-extreme fatigue, severe muscular pain, ial pilots —ei quit the service or submitted| to court-martial pi for refising the shot. Two years ago,the Pentagon received more bad news — about 600,000 doses in the stockpile failed potency tests. In July 2000, the Pentagon greatly reduced the number of personnel intended for anthrax immunization. So far, fewer than onefourth of the 2 million-plus troops originally slated to receive the vaccine had been immunized. More communication gaps developed. The GAO saysit found a 1994 Defense Departmentstudythat speculated that to the FDA onOct. 15. When Dr. Anna JohnsonWineger — chief of the Pentagon’s biochemical defense programs — was asked about the delay, shetold GNS, “We'lljust try to be more diligent in the future.” The GAOalso said it found “published and unpublished data” on anthrax vaccine use that “showed a significantly greater incidence of both local and systemic adverse reactions compared with rates reported in the product insert.” 30-50%OFF GALAXY COLLECTION OF CUSTOM DRAPERIES & TOP TREATMENTS CALL TODAY FOR YOUR FREE IN-HOME CONSULTATION extra 1-800-543-5436 a itSallinside: off custom decorating ra a4 Ce) aa Gar Install by Christmas | Entire stock of antique, semi- poor vision, dulling of reflexes, and repetitive headaches. 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