IS THE POLIO VACCINE A TICKING TIME BOMB?

The development of the Salk polio vaccine has been called one of the greatest medical achievements of the century. Today, however, there is growing fear that early stocks of the vaccine may also have contained a ticking time bomb that holds the seeds of a new and frightening epidemic of cancer and autoimmune disease. What is disturbing, though, is the appearance that government officials have withheld information concerning this potential threat from the public for over four decades. Even more disturbing is the fact that the cover-up continues to this day.

THE POLIO VACCINE

During the first half of the 20th century, the word "polio" conjured up visions of paralysis, iron lungs and early death. In 1952, the peak year, the dread disease struck 57,000 Americans and claimed 3,000 lives. Then, a medical miracle occurred. On April 12, 1955 Dr. Jonas Salk announced that he had developed a vaccine that provided protection against poliomyelitis. The same day, the federal government licensed the Salk vaccine for distribution. Salk declined to patent the vaccine saying he had no wish to profit from his discovery and wanted to see it made as widely available as possible. Soon, millions of Americans were being inoculated.

The Salk vaccine was prepared by growing the polio virus on tissue taken from the kidneys of rhesus monkeys. Once harvested, the virus was then "killed" by exposing it to formaldehyde. When someone was injected with a vaccine produced from the "killed" virus, their body would react as though it had been infected and begin producing antibodies to attack the invading disease cells. The advantage of using a "killed" virus in the vaccine is that there was little risk of the recipient actually contracting polio.

Between 1955 and 1961, some 98 million Americans - more than 60% of the population -- were given the Salk vaccine, and the incidence of polio began a dramatic decline. What they did not know, was that when vaccinated, some people got more than just an immunization against polio.

A DISTURBING DISCOVERY

In 1959, Bernice Eddy, a researcher at the National Institutes of Health had made a disturbing discovery. While examining rhesus monkey cells - the same type used to make the Salk vaccine -- under a microscope, she noticed that some were dying without any obvious cause. Concerned, she ran further tests, taking extracts from rhesus monkey kidneys and injecting them into 23 hamsters. Within months, 20 of the 23 test animals had developed "large, malignant subcutaneous tumors."

Alarmed, on July 6, 1960, Eddy went to her boss, Dr. Joseph Smadel and reported her findings. Smadel dismissed the tumors as "lumps." He could not have been more wrong.

At about the same time that Eddy was conducting her experiments, two researchers working for the Merck pharmaceutical company, Drs. Maurice Hilleman and Ben Sweet, had isolated a new virus from kidney tissue of rhesus monkeys. The 40th such virus discovered, it was called SV 40.

In 1961, the new Sabin oral polio vaccine, which used a live virus, was introduced. The Sabin vaccine promised lifelong immunity to both paralysis and infection, and was easier to administer. Eventually, both the Salk and Sabin vaccines would be administered to patients in alternating doses.

But there was a problem.

In the course of routine testing, it was discovered that batches of both the Sabin and Salk vaccines were contaminated with the SV 40 virus. Some estimates indicated that as much as a third of the Salk vaccine that had been administered was tainted. Worse, additional testing had confirmed what Dr. Eddy had feared - that the SV 40 virus was causing cancer in lab animals.

IGNORING THE THREAT

The government moved swiftly to ensure that future batches of polio vaccine were free of the SV 40 virus, but allowed existing stocks to be used. More important, government officials decided not to notify the public of the potential danger out of fear that it would cause panic and interfere with the vaccination campaign. Indeed, the only public mention of the problem was a story buried on page 33 of the New York Times. It said that polio vaccine manufacturers were suspending production to remove a monkey virus from the vaccine. The story also said that the Public Health Service said that the virus was not dangerous - even though there was no basis for such an assertion!

The following year, the National Cancer Institute assigned Dr. Joseph Fraumeni the task of determining whether recipients of the vaccine demonstrated any increase in cancer. He tested samples of the vaccine administered in May and June of 1955 to measure their extent of SV 40 contamination - whether it was high, low or uncontaminated. He then determined where the vaccine had been distributed and examined cancer mortality rates among children who had been vaccinated at that time.

His findings - that there was no significant difference in cancer deaths among children in the states examined regardless of the presence or lack of SV 40 - were published in the Journal of the American Medical Association. That, as far as the federal government was concerned was that. No consideration was given to the fact that there might be a time lag of decades before a virus-related cancer appeared, or that he had selected a relatively narrow sample. His study cleared the way for continuing polio vaccination and that is what the federal medical establishment wanted.

Over the intervening years, however, reports began to surface linking SV 40 to human cancers. As the evidence mounted, Fraumeni decided to take a second look at the issue. This time he selected a group of 1,073 black children who had been given the Sabin oral vaccine in a test conducted at Cleveland Metropolitan General Hospital. It was known that the batch used in this test was contaminated with SV 40. Letters were sent to the vaccine recipients, now young adults aged 17 to 19. Less than half responded. The researchers failed to find evidence of SV 40 related health problems, and so once again, the threat was dismissed. As with the earlier study there were fatal flaws with the 1976-79 review as well.

An analysis of Fraumeni's methodology published in the 1982 New England Journal of Medicine was critical on a number of points. First, it noted that a majority of the vaccine recipients had not responded, greatly limiting the potential validity. Secondly, it noted that the types of cancers associated with SV 40 might easily take more than 17 to 19 years to develop. Finally, and perhaps most important, it noted that it appeared that individuals who were given the Sabin vaccine were much less likely to be infected by the SV 40 virus than those given the Salk vaccine.

Despite these obvious flaws, government officials took the Fraumeni study as more proof that SV 40 was not a threat.

Soon more disturbing data would emerge...

A NEW TECHNOLOGY REVEALS THE HIDDEN DANGER

In 1988, Dr. Robert Garcea and Dr. John Bergsagel were investigating common human viruses in childrens' brain tumors with a new technique called polymerase chain reaction or PCR. The technique allows researchers to identify small bits of DNA in tissue samples. As they conducted their tests, half of the brain tumor samples showed signs of an unidentified DNA strand. Concerned, they continued to investigate and discovered that the DNA they kept finding was from the SV 40 virus. What was a particular concern to the researchers was that the tumor samples had all come from children too young to have been infected from batches of the polio vaccine known to be contaminated.

At about the same time, Dr. Michele Carbone of the National Institutes of Health discovered a type of tumor called a mesothelioma in hamsters injected with the SV 40 virus. What concerned Carbone was that the SV 40 had been injected into the hamsters hearts, but the tumors were on the lining of their lungs. This suggested that extremely small amounts of the virus carried by the tip of the needle used to inject the hamsters' hearts had caused the cancer.

It was present in 60% of the test animals

To confirm his suspicions, Carbone injected the SV 40 virus directly into the mesothelial walls (linings of the body's major cavities) of hamsters. Every animal so treated developed the rare cancer mesothelioma. What concerned Carbone even more was the fact that although most cases of mesothelioma in humans was linked to asbestos exposure, roughly a fifth of the cases involved people who had not been exposed to the carcinogen. Could SV 40 be the missing link?

Carbone decided to find out by running PCR tests on four dozen samples of human mesothelioma tumors stored at NIH. To his shock, 28 of them contained the SV 40 virus.

Carbone's findings were a signal to other cancer researchers to look for the SV 40 virus in connection with other rare cancers. Over the next several years, the evidence mounted.

ANOTHER BOMBSHELL

By 1996, the evidence was becoming clear. Scientists around the world were discovering the SV 40 virus present in a wide variety of bone and brain cancers. More important, the incidence of all of these cancers had been rising sharply over the previous two decades. Still, the question remained of how the virus had become so widespread. Then, Italian scientists made a startling discovery.

In 1996, Italian researchers tested blood and body fluid samples from a number of healthy individuals. Fully 45 percent were found to have the SV 40 virus in their semen, and 23% in their blood. This meant that even people who had not taken the vaccine might be at risk.

Despite these increasingly strong indications that something was amiss, the medical establishment resisted the notion that the SV 40 virus was a problem. At the National Cancer Institute, Dr. Fraumeni the author of the studies which said that SV 40 was not a problem, was now head of the Division of Cancer Epidemiology and Genetics. Since his findings were being challenged he dispatched one of his employees, Dr. Howard Strickler, to do yet another study of SV 40.

Strickler tested 50 samples of mesotheliomas taken from military hospitals for SV 40 using the PCR technique. His findings were negative. He then embarked on a study measuring cancer rates among persons who were born between 1947 and 1961, the age cohort that had received the contaminated vaccine. He compared them with people born after 1963 when the vaccine was supposed to be SV 40 free.

Strickler presented his findings at a conference in January of 1997 along with additional results from a study comparing cancer rates among people born between 1947 and 1963 with those among people born after 1963. There was no difference in the rates he concluded, and therefore no problem.

Or was there?...

A FLAWED STUDY

When Dr. Susan Fisher of the Loyola University Medical Center read the conclusions of Strickler's study in the Journal of the American Medical Association, she was incensed. She wrote to JAMA criticizing Strickler's methodology as "an error in judgement" - strong words among medical academics. The problem, she believed, was that Strickler had failed to take into account the fact that "cancers are highly correlated with age." When she took this factor into account, she discovered several disturbing facts.

Among 18 to 26 year-olds, the group most likely exposed to contaminated vaccine - the incidence of brain cancer, including two types linked to SV 40, was 19.6 percent higher than among those not exposed. The incidence of bone cancer was 16.6 percent higher. Most disturbing, the incidence of the previously rare mesothelomias was 178 percent greater among individuals exposed to vaccine contaminated with SV 40 than among those who were not.

Fisher, however, was also concerned that making comparisons based on whether or not people had received contaminated vaccine might be invalid on its face. The reason for her concern was that there were reports of SV 40 being transmitted between people who had taken the tainted vaccine and those who had not.

Soon, another shoe dropped.

THE SECOND STRAIN

In 1999, a number of vials of the Salk vaccine dating from 1955 were discovered. Dr. Michael Carbone, who was now at the Loyola University Medical Center, tested the samples. Carbone was stunned by the test results. He discovered that there were actually two strains of the SV 40 virus present. More disturbing, while the original strain appeared within 14 days, the second strain took 14 days to emerge. Therefore, it would not be detected by the tests intended to eliminate the SV 40 virus from the polio vaccine!

Even though Carbone's discovery of the second SV 40 virus strain provided a possible explanation of how its DNA could be present in the tumors of people who took the polio vaccine after 1963, the government continued to resist the notion of an SV 40 - cancer link. Strickler claimed that the presence of SV 40 in tumor samples must be the result of contamination at the laboratories where the tests were performed. NIH commissioned a study of samples from nine laboratories to determine whether this was the case. The only trouble was that such a study had already been conducted, and proved that contamination was not the problem. Still Strickler persisted in his crusade to discredit the SV 40 - cancer link.

Unsurprisingly, the NIH lab study found virtually no SV 40 presence in tumor samples from the nine labs. Critics, however, argued that the NIH review was flawed, and the fur began to fly. Finally the FDA stepped in and appointed an arbitrator to decide who was right. The arbitrator said contamination was not the problem but was at a loss to explain the apparently contradictory findings.

Meanwhile, more and more scientists around the world were discovering the SV 40 virus in tumor samples - especially those of the previously rare mesotheliomas. In August of last year, Dr. Carbone came up with yet another startling discovery. He found that in meosthelial cells, the presence of the SV 40 virus accelerated the rate at which healthy cells changed into cancer cells 1000 times. Apparently, the SV 40 virus acted as a co-carcinogen suppressing the immune system's response to cancer!

Yet, the NCI and NIH continued to turn a blind eye to the problem.

At a conference in August of 2001, Dr. Carbone expressed his exasperation at the government's "head in the sand" attitude.

"Sixty-two papers from 30 laboratories around the world have reported SV 40 in human tissues and tumors. … It is very difficult to believe that all of these papers, all of the techniques used and all of the people around the world are wrong."

With such dramatic evidence, the National Cancer Institute has finally acknowledged that SV 40 "may be associated with human cancer," but their response to this finding has been less than enthusiastic.

While Dr. James Goedert, who heads up the NCI's Viral Epidemiology Branch insists that the government isn't hiding anything, he does acknowledge that SV 40 is "… not one of our highest priorities."

While the NCI scientists hide their heads in the sand, other researchers around the world are discovering additional cause for concern over SV 40.

NIH researcher Dr. Jeffery Kopp has uncovered an unsettling connection between SV 40 and a new and deadly form of kidney disease. Prior to 1980 so-called "collapsing" renal disease was unknown. Since that time, however, it has been rapidly increasing. Kopp found that a large percentage of people with kidney disease had the SV 40 virus present in their system. More important fully 60% of those with the new, virulent "collapsing variety" showed evidence of SV 40.

But the mystery of how people who had not received contaminated vaccine could end up with the SV 40 virus remained. That is, if the vaccine produced after April of 1961 was truly free of the SV 40 virus.

NEW REVELATIONS

The San Francisco Chronicle has uncovered documents that show that polio vaccine produced years after the 1961 order that it be free of SV 40 may well have been contaminated. Among the most damaging was an internal memorandum from Lederle indicating that in November of 1961, seven months after the ban had taken effect, the company was allowed to distribute 15 lots of the vaccine even though three of them were found to be contaminated with SV 40. According to the Chronicle, the memo said that the decision to release them came from Dr. Roderick Murray, the person in charge of the federal program to ensure vaccine purity!

What makes this memo even more of a concern is an October, 1962 letter from Albert Sabin to Lederle warning that one of the strains of poliovirus used to manufacture his version of the vaccine had not been adequately tested.

Other Lederle memos Kops uncovered suggest that the additional tests Sabin believed necessary were never performed. Indeed, as recently as 1997, according to Lederle documents, test results from many lots of polio vaccine were missing. There can be no assurance that some of them did not contain SV 40.

Kops is sure that they did.

He and another lawyer are suing on behalf of the family of Mark Moreno, who had a large brain tumor removed in 1970, and has required multiple operations since. Tests of tissue samples from his brain tumor show it is riddled with SV 40. His parents are certain he was infected with the virus when he took the oral polio vaccine in 1968 - fully seven years after it was supposed to be SV 40 free.

Although the government recently tested 30 bulk samples of the polio vaccine for SV 40, the samples only went back to 1972. The government claims it only tested that far back because samples of earlier vaccine were not available. It is not clear, however, whether the tests included the second strain of SV 40 that Dr. Carbone discovered in 1999 - an important fact since it takes longer to show up. The FDA, however, insists that the problem does not exist.

Soon, however, the government may be forced to take a serious look at the problem. A suit was filed in Los Angeles last year against Lederle by the parents of Alexander Horwin, who died of a brain tumor at the age of 2 and a half. Like Mark Moreno's, Alexander's tumor was riddled with SV 40. His parents believe he was infected when he took the oral polio vaccine in 1997. As his suit and the one filed by Mark Moreno's parents make their way through the courts, the truth may finally be revealed. Even if the truth does come out, though, it may prove small consolation for countless millions who were given contaminated polio vaccine - vaccine the FDA encouraged them to take, and assured them was safe!

The FDA's scandalous disregard of the evidence that the polio vaccine was and may still be contaminated is yet another example of the agency's failure to fulfil its statutory responsibility to protect the public from unsafe pharmaceutical products! Time and time again, their actions seemed more aimed at protecting drug company profits than ensuring public safety. It is time for the American public to rise up and say ENOUGH!

We must write our elected officials and demand that they take action to make the FDA responsive to the public will. We must make them understand that our patience is at an end! Most important, we must tell our representatives that if they do not act, we will replace them with people who will. In America, power is supposed to be vested in the people. The FDA seems to have forgotten this fact. It is time they were reminded!