Anthrax Vaccine Maker Didn't Report Army Sergeant's Death, According to FDA
By Dave Eberhart
Stars and Stripes, Veterans Affairs Editor
Anthrax Vaccine Maker Didn't Report Army Sergeant's Death, According to FDA.
The Pentagon's lone anthrax vaccine manufacturer failed to report a vaccine-related death that occurred in June 2000, according to an Oct. 26, 2000, Food and Drug Administration report of an inspection at the BioPort Corp. plant in Lansing, Mich.
BioPort also failed to investigate or react to reports by the Pentagon's Vaccine Adverse Event Reporting System (VAERS) of servicemembers becoming ill after receiving one or more shots in the DoD's Anthrax Vaccine Inoculation Program (AVIP), according to the report, a copy of which was obtained by The Stars and Stripes.
The FDA said: "The military reported a death of an individual who had received Anthrax vaccine lot #FA V031. The individual was inoculated on 3/14/00 and died on 6/14/00. The cause of death is reported as Aplastic Anemia and Invasive Aspergillosis. The firm received information in a VAERS form but there is no documentation as to when that report was received by the firm [BioPort]."
Blood Disorder
Redmond Handy, president of the National Organization of Americans Battling Unnecessary Servicemember Endangerment (NO ABUSE), told The Stars and Stripes Feb. 5 that the servicemember involved was Sandra Larson, an Army sergeant whose sister, Nancy Rugo, testified before the House Government Reform Committee last year that Larson had died of an autoimmune blood disorder. She said Larson had blamed the anthrax vaccine for her illness.
Rugo told lawmakers that Sandra Larson joined the Army in 1995 and was transferred to South Korea in 1998, where she began the 18-month vaccine program and received four of the six required shots from lot 17. In October 1999 she was transferred to Fort Riley, Kan., where she received the final two shots, from lot 44 in September of that year and from lot 31 in March 2000.
"On April 7, 2000, just four weeks after being injected from her sixth shot, [Sandra Larson] was admitted into the hospital with a serious rare blood disease, aplastic anemia, which could be considered an autoimmune disease," Rugo testified. "On June 14, 2000, twelve weeks after receiving her sixth shot, she had deceased."
"This was not a gradual case of aplastic anemia," Rugo said. "She went from a healthy woman just four weeks prior to having no bone marrow, platelets and an extremely low count of red and white blood cells. It was as if there was something in her that was killing her immune system, shutting her down."
"The firm [BioPort] has not reported the death to FDA in a 15-day report. The firm has not conducted an investigation [of the death] as a result of this VAERS report," said the FDA report, which was prepared by inspectors Marsha W. Major, William D. Tingley and Paula A. Trost.
'No Documentation'
And, the report said, "The firm does not trend data received relating to adverse events. Further, there is no documentation to show that the firm investigates adverse events [drug reactions] when received."
Uninvestigated adverse events included "nausea, diarrhea, vomiting, double vision, dizziness, memory loss, shortness of breath, and blackouts," the inspectors reported.
The FDA report identified three anthrax vaccine lots that failed initial sterility testing. One lot "was retested and failed the retest," the report said. The FDA characterized BioPort's investigations into the initial sterility test failures as incomplete and "not addressing corrective actions relating to [BioPort] personnel."
The report cited a "lack of reconciliation of vials that are returned to the firm from customers" on the part of BioPort. In one instance, according to the report, BioPort was discovered to have changed its records on the number of anthrax vaccine vials returned by the military for destruction.
Larson's death is being investigated by several organizations, including the FDA and the anthrax vaccine expert committee, a group of civilian physicians that reviews VAERS reports.
Bioport
BioPort spokeswoman Kim Brennan Root told The Stars and Stripes Feb. 6 that Larson's death "is being investigated by several organizations, including the FDA and the anthrax vaccine expert committee, a group of civilian physicians that reviews VAERS reports." The committee members are appointed by the FDA, Root said.
Probe 'Not Complete'
"What we'll do is an investigation based on that report" by the committee, Root said. "I'm not sure what that investigating will be. In my opinion, the investigation is not complete."
Referring to the VAERS report of Larson's death, Root said: "That is the first VAERS report filed by the military implicating the vaccine that we know of."
Root's response concerning the reported lack of a timely reaction to the Larson VAERS: "We received that report the day the FDA inspectors arrived [Oct. 6, 2000]." She said that BioPort has since put new software into play "to turn that data in a way that will be compliant with the way FDA wants us to do it."
Robert C. Myers, BioPort's chief scientific officer, earlier had defended the vaccine and his company's manufacturing process, saying: "Now licensed for thirty years, with two million doses given in the last two and a half years alone, the vaccine is proven safe. In total, there have been 13 safety studies of many different types involving 366,000 patients and there is no pattern emerging that would call the vaccine's safety into question."
"Anthrax vaccine is also purer than the diphtheria and tetanus vaccines we give our children and is safe or safer than these and other vaccines we give to our children and take ourselves as adults," he said.
And a Pentagon spokesmen said: "Thirty years of experience with anthrax vaccine in the United States suggests that it has a side-effect profile similar to other commonly used vaccines. The Army is conducting a long-term, prospective study using a cohort of 600 soldiers at Tripler Army Medical Center in Honolulu. The intent is to identify side effects that may be associated with the anthrax vaccine. Thirteen human safety studies affirm the safety of anthrax vaccine."
Production Quotas Dr. Meryl Nass, a longtime AVIP critic, told The Stars and Stripes Feb. 6: "I feel just as I did when I commented on the first inspection report I ever saw of BioPort in early '98: It looks as if the manufacturer was solely trying to meet production quotas, with no thought ever being paid to the fact that this product would be injected into human beings."
"The amazing thing is that after three years of similar inspection reports, millions of taxpayer dollars and a multitude of experts, they remain so far off the mark," said Nass. "Where is the quality assurance? I sent a Canadian bio-defense expert a copy of a BioPort inspection report, and he said he couldn't sleep that night."
FDA Warned BioPort of Mad Cow
Bovine-derived materials have traditionally been used in the manufacture of vaccines. Bovine spongiform encephalopathy (BSE), the deadly "mad cow disease," was first reported in the United Kingdom in the 1980s. Animal-derived products used in vaccine production can include amino acids, glycerol, detergents, gelatin, enzymes and blood.
To minimize the possibility of contamination, the FDA, in 1993 and again in 1996 recommended that manufacturers, including BioPort, not use materials derived from cattle that were born, raised or slaughtered in countries where BSE is known to exist. The FDA also alerted manufacturers to a U.S. Department of Agriculture list of countries producing potentially BSE-tainted beef.
But despite such warnings, the FDA's Center for Biologics Evaluation and Research last fall reported that BioPort was still using bovine-derived materials of unknown geographical origin.
Stars and Stripes, Veterans Affairs Editor
Anthrax Vaccine Maker Didn't Report Army Sergeant's Death, According to FDA.
The Pentagon's lone anthrax vaccine manufacturer failed to report a vaccine-related death that occurred in June 2000, according to an Oct. 26, 2000, Food and Drug Administration report of an inspection at the BioPort Corp. plant in Lansing, Mich.
BioPort also failed to investigate or react to reports by the Pentagon's Vaccine Adverse Event Reporting System (VAERS) of servicemembers becoming ill after receiving one or more shots in the DoD's Anthrax Vaccine Inoculation Program (AVIP), according to the report, a copy of which was obtained by The Stars and Stripes.
The FDA said: "The military reported a death of an individual who had received Anthrax vaccine lot #FA V031. The individual was inoculated on 3/14/00 and died on 6/14/00. The cause of death is reported as Aplastic Anemia and Invasive Aspergillosis. The firm received information in a VAERS form but there is no documentation as to when that report was received by the firm [BioPort]."
Blood Disorder
Redmond Handy, president of the National Organization of Americans Battling Unnecessary Servicemember Endangerment (NO ABUSE), told The Stars and Stripes Feb. 5 that the servicemember involved was Sandra Larson, an Army sergeant whose sister, Nancy Rugo, testified before the House Government Reform Committee last year that Larson had died of an autoimmune blood disorder. She said Larson had blamed the anthrax vaccine for her illness.
Rugo told lawmakers that Sandra Larson joined the Army in 1995 and was transferred to South Korea in 1998, where she began the 18-month vaccine program and received four of the six required shots from lot 17. In October 1999 she was transferred to Fort Riley, Kan., where she received the final two shots, from lot 44 in September of that year and from lot 31 in March 2000.
"On April 7, 2000, just four weeks after being injected from her sixth shot, [Sandra Larson] was admitted into the hospital with a serious rare blood disease, aplastic anemia, which could be considered an autoimmune disease," Rugo testified. "On June 14, 2000, twelve weeks after receiving her sixth shot, she had deceased."
"This was not a gradual case of aplastic anemia," Rugo said. "She went from a healthy woman just four weeks prior to having no bone marrow, platelets and an extremely low count of red and white blood cells. It was as if there was something in her that was killing her immune system, shutting her down."
"The firm [BioPort] has not reported the death to FDA in a 15-day report. The firm has not conducted an investigation [of the death] as a result of this VAERS report," said the FDA report, which was prepared by inspectors Marsha W. Major, William D. Tingley and Paula A. Trost.
'No Documentation'
And, the report said, "The firm does not trend data received relating to adverse events. Further, there is no documentation to show that the firm investigates adverse events [drug reactions] when received."
Uninvestigated adverse events included "nausea, diarrhea, vomiting, double vision, dizziness, memory loss, shortness of breath, and blackouts," the inspectors reported.
The FDA report identified three anthrax vaccine lots that failed initial sterility testing. One lot "was retested and failed the retest," the report said. The FDA characterized BioPort's investigations into the initial sterility test failures as incomplete and "not addressing corrective actions relating to [BioPort] personnel."
The report cited a "lack of reconciliation of vials that are returned to the firm from customers" on the part of BioPort. In one instance, according to the report, BioPort was discovered to have changed its records on the number of anthrax vaccine vials returned by the military for destruction.
Larson's death is being investigated by several organizations, including the FDA and the anthrax vaccine expert committee, a group of civilian physicians that reviews VAERS reports.
Bioport
BioPort spokeswoman Kim Brennan Root told The Stars and Stripes Feb. 6 that Larson's death "is being investigated by several organizations, including the FDA and the anthrax vaccine expert committee, a group of civilian physicians that reviews VAERS reports." The committee members are appointed by the FDA, Root said.
Probe 'Not Complete'
"What we'll do is an investigation based on that report" by the committee, Root said. "I'm not sure what that investigating will be. In my opinion, the investigation is not complete."
Referring to the VAERS report of Larson's death, Root said: "That is the first VAERS report filed by the military implicating the vaccine that we know of."
Root's response concerning the reported lack of a timely reaction to the Larson VAERS: "We received that report the day the FDA inspectors arrived [Oct. 6, 2000]." She said that BioPort has since put new software into play "to turn that data in a way that will be compliant with the way FDA wants us to do it."
Robert C. Myers, BioPort's chief scientific officer, earlier had defended the vaccine and his company's manufacturing process, saying: "Now licensed for thirty years, with two million doses given in the last two and a half years alone, the vaccine is proven safe. In total, there have been 13 safety studies of many different types involving 366,000 patients and there is no pattern emerging that would call the vaccine's safety into question."
"Anthrax vaccine is also purer than the diphtheria and tetanus vaccines we give our children and is safe or safer than these and other vaccines we give to our children and take ourselves as adults," he said.
And a Pentagon spokesmen said: "Thirty years of experience with anthrax vaccine in the United States suggests that it has a side-effect profile similar to other commonly used vaccines. The Army is conducting a long-term, prospective study using a cohort of 600 soldiers at Tripler Army Medical Center in Honolulu. The intent is to identify side effects that may be associated with the anthrax vaccine. Thirteen human safety studies affirm the safety of anthrax vaccine."
Production Quotas Dr. Meryl Nass, a longtime AVIP critic, told The Stars and Stripes Feb. 6: "I feel just as I did when I commented on the first inspection report I ever saw of BioPort in early '98: It looks as if the manufacturer was solely trying to meet production quotas, with no thought ever being paid to the fact that this product would be injected into human beings."
"The amazing thing is that after three years of similar inspection reports, millions of taxpayer dollars and a multitude of experts, they remain so far off the mark," said Nass. "Where is the quality assurance? I sent a Canadian bio-defense expert a copy of a BioPort inspection report, and he said he couldn't sleep that night."
FDA Warned BioPort of Mad Cow
Bovine-derived materials have traditionally been used in the manufacture of vaccines. Bovine spongiform encephalopathy (BSE), the deadly "mad cow disease," was first reported in the United Kingdom in the 1980s. Animal-derived products used in vaccine production can include amino acids, glycerol, detergents, gelatin, enzymes and blood.
To minimize the possibility of contamination, the FDA, in 1993 and again in 1996 recommended that manufacturers, including BioPort, not use materials derived from cattle that were born, raised or slaughtered in countries where BSE is known to exist. The FDA also alerted manufacturers to a U.S. Department of Agriculture list of countries producing potentially BSE-tainted beef.
But despite such warnings, the FDA's Center for Biologics Evaluation and Research last fall reported that BioPort was still using bovine-derived materials of unknown geographical origin.
