|Polio vaccine might have carried virus
Press International | September 9, 2003
WASHINGTON, Sept. 9 (UPI) -- Some of the polio vaccine given to millions of American children from 1962 until 2000 could have been contaminated with a monkey virus that shows up in some cancers, according to documents and testimony to be delivered to a House committee Wednesday. The vaccine manufacturer said such claims "don't have any validity," and the Centers for Disease Control and Prevention agrees.
Some batches of the first polio vaccine used from 1955 until 1962 were contaminated with the monkey virus. The virus has also been found in some cancer in humans, although it has not been determined that the virus caused the cancer. Between 10 and 30 million Americans may have received a contaminated dose of that vaccine, according to the Centers for Disease Control and Prevention.
The monkey virus is suspected of causing cancer in laboratory animals, including brain cancers, bone tumors and a usually fatal cancer in the membranes around the lungs called mesothelioma.
But it has been widely assume that the replacement for the Salk vaccine, a live oral polio vaccine called the Sabin oral vaccine, was free of Simian Virus 40, or SV40. That vaccine was used from 1963 until 2000, when it too was replaced.
Documents set to be delivered to the House Subcommittee on Human Rights and Wellness appear to show that the original "seeds" used to produce the Sabin vaccine could have been tainted with SV40; that the company that manufactured the vaccine, Wyeth Lederle, may have used Rhesus monkeys -- which are more likely to carry the disease -- rather than the African Green monkeys it says it used, according to company documents; and that the company may not have performed all of the screening tests required.
Stanley P. Kops, an attorney who represents clients he says were "paralyzed, killed and-or severely damaged" by the vaccine used until 2000, will present the documents. Kops alleges in his written testimony that the manufacturer and the FDA were negligent and failed to protect children.
"There is a history of negligence involving this vaccine manufacturer and the regulators," Kops says in his written testimony. "The vaccine safety tests were not submitted [to the FDA], the regulators did not look, and infants in the United States became paralyzed or died, and there are now clear instances of cancer reported in the children and individuals who received this product."
A spokesperson for Wyeth Lederle, Natalie de Vane, said Kops is wrong.
"These claims don't have any validity," said de Vane. "In response to allegations such as this, the FDA went back and tested batches that were released between 1976 and 1989 and using the most advanced methods of testing available, found no evidence of SV40. We have always conducted extensive screening and testing of our products. The FDA monitors this."
A Food and Drug Administration spokesperson was unaware of the allegations. A CDC fact sheet says that "all of the current evidence indicates that polio vaccines have been free of SV40 since 1963."
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, will tell the committee that the polio vaccine story is particularly troubling. The center does not accept money from vaccine manufacturers.
"At the hear of this tragic story is a violation of the public trust and the informed consent ethic," Fisher says in her testimony.
Kops says his documents show the following:
-- A decades-old letter from Dr. Albert B. Sabin to Lederle Laboratories saying that the original "seed" used to make the Sabin vaccine may not be free of SV40 contamination. The letter says that Sabin "could not be certain that there may not be a trace of SV40 virus in this material."
-- On Oct. 2, 2002, the Wyeth Lederle head of biological quality control said in a deposition that the company did not routinely perform blood tests on monkeys used to make the vaccine to make sure the monkeys did not carry SV40.
-- Company protocols show that a "cell batch" used to make vaccines might not be rejected even if SV40 is found in some test results.
-- Company documents describe the use of "rhesus" monkeys, apparently to make the vaccine. Wyeth Lederle says it did not use rhesus monkeys.
-- A Dec. 16, 1960, letter from Merck & Co. to the U.S. Public Health Service saying that company would not join the business of producing the oral vaccine because the risk of SV40 contamination was too high. The company told the government that it is "extremely difficult" to eliminate monkey viruses and "impossible to detect."