However, during clinical trials against Dryvax, it was discovered that the Acambis vaccine, ACAM2000, might cause heart inflammation so Acambis has stopped adding participants to the study while it is being reviewed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
At least one volunteer experienced heart inflammation after receiving the vaccine. Several dozen people also exhibited heart inflammation last year when the government immunized health care workers and military personnel with the smallpox vaccine.
As quoted in the Washington Post article, Meryl Nass, a Maine-based physician who is a frequent critic of the government's vaccination programs, said these developments indicate that federal authorities erred when they devoted such massive amounts of money to ACAM2000 before the potential side effects were known. "Nobody in the real world orders huge quantities of any drug or vaccine before it's been tested," she said.
Washington Post April 14, 2004
Comment By Dr. Meryl Nass:
Although on 9/11/01 the government knew it had at least 90 million doses of stockpiled smallpox vaccine that could be diluted five times and maintain 99 percent effectiveness (i.e. 450 million vaccine doses were already available for emergency use), the Department of Health and Human Services (DHHS) went ahead and contracted (for $850 million) with Acambis, a tiny startup company, to supply a total of 209 million more doses of vaccine before any testing was done and the nature of the new vaccine had even been decided. No "stopgap" was needed, since we already had one.
Meanwhile, military troops continue to receive Dryvax smallpox vaccine routinely. Over 500,000 have been vaccinated. By using rigid inclusion criteria and passive surveillance to limit case-finding, the military has claimed that only one in 14,000 troops have developed myopericarditis (heart inflammation).
Yet in the Acambis trial, more than one in a thousand volunteers developed this same cardiac complication, a rate 15 times higher than the military reports. But no U.S. government agency has made any attempt to halt the military vaccine program.
Further, if you look at the FDA-approved label for Dryvax smallpox vaccine (PDF), on pages 3 to 4, under INDICATIONS, you will notice that the FDA appears to have one set of indications (approved reasons for its use) for civilians, while allowing the military to define its own, different and unapproved, reasons for use of the vaccine in soldiers.
After listing the approved uses of the vaccine, the product label then points out that the military has its own regulations and directives on use of smallpox vaccine. This sleight-of-hand was used by FDA to abdicate its role of regulating the appropriate use of vaccine for all Americans, including those in military service.
Meryl Nass MD is a practicing physician who is known for investigating the world’s largest anthrax epidemic, which occurred during the Rhodesian Civil War, and uncovering its cause as biological warfare; for working to strengthen international controls against the development and use of biological weapons; and for pointing out that untested drugs and vaccines (such as those for smallpox and anthrax) have limited effectiveness and cause unexpected illnesses. She has lectured widely, testified before several committees of Congress and the Institute of Medicine, and been quoted by all major U.S. newspapers and TV networks, and many international news outlets. Since 9/11, she has pointed out how to deal with an anthrax attack, and explained that the United States must pursue more creative approaches if it is to successfully cope with future biological terrorism. Unencumbered by funding from the government and biodefense industry, she provides the unique perspective of a well-informed and candid critic of our current approach to bioterrorism.
Meryl Nass MD is a practicing physician who is known for investigating the world’s largest anthrax epidemic, which occurred during the Rhodesian Civil War, and uncovering its cause as biological warfare; for working to strengthen international controls against the development and use of biological weapons; and for pointing out that untested drugs and vaccines (such as those for smallpox and anthrax) have limited effectiveness and cause unexpected illnesses.
She has lectured widely, testified before several committees of Congress and the Institute of Medicine, and been quoted by all major U.S. newspapers and TV networks, and many international news outlets.
Since 9/11, she has pointed out how to deal with an anthrax attack, and explained that the United States must pursue more creative approaches if it is to successfully cope with future biological terrorism. Unencumbered by funding from the government and biodefense industry, she provides the unique perspective of a well-informed and candid critic of our current approach to bioterrorism.
Related Articles:
The Controversial Smallpox Vaccine -- Eighteen Points You Should Consider Will Three Unlicensed Smallpox Vaccines Be Used to Immunize 500,000 Americans? Smallpox Outbreak Reactions to Smallpox Vaccine Alarm Experts Sanitation Vs. Vaccination - The Origin of Smallpox Smallpox Vaccine Has the Pox
The Controversial Smallpox Vaccine -- Eighteen Points You Should Consider
Will Three Unlicensed Smallpox Vaccines Be Used to Immunize 500,000 Americans?
Smallpox Outbreak
Reactions to Smallpox Vaccine Alarm Experts
Sanitation Vs. Vaccination - The Origin of Smallpox
Smallpox Vaccine Has the Pox