by Sherri Tenpenny, DO, AOBNMM, ABIHM
THE VIRUS AND THE VACCINE, by Debbie Bookchin and Jim Schumacher, is an impeccably researched expose’. Beyond the documenting the historical saga of the polio vaccine and SV40, this book has a much larger and more foreboding message. The book definitively connects the incestuous interrelationships between the federal government, the major governmental health agencies [the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Disease Control (CDC) and the National Cancer Institute (NCI)] and the pharmaceutical industry. If there were ever any misgivings as to how deeply enmeshed these groups are, this book removes all doubt. The impeccable research exposes the extensive use of power, coercion and cover up used to maintain the public’s “confidence in vaccines.”
It goes something like this:
• A researcher documents a serious problem with a vaccine.
• The government publishes a “definitive study” to “set the record straight.”
• A flurry of media campaigns and medical journal articles are commenced ensure support the conclusions of the “definitive study.”
• Upon critical examination, the “definitive study” is found to have serious flaws. Although broadcast via many venues—through government hearings, journal publications, radio broadcasts and over the internet—the rebuttals are barely acknowledged. The “definitive study” becomes “established medical fact.”
• Pressure from the public watchdog groups is placed on Congress to force the hand of the government agencies. Hearings are held to give the appearance of concern. But instead of acting decisively, the hallmark of government committee meetings becomes to delay a decision by using the justification, “temporal association does not prove causality.”
Identifying a problem: Dangerous to your career.
In 1959, researcher Dr. Bernice Eddy, from the National Institutes of Health (NIH), the Division of Biological Standards (DBS) was working with Dr. Sarah Stewart from the National Cancer Institute (NCI). Together, the two proved that a mouse virus could cause cancer when it was injected into other small animals. Both researchers received national recognition for their discovery, and Stewart’s reward including being put in charge of her own laboratory at the NCI.
Upon returning to the DBS, Eddy began to question if the simian viruses she found in the monkey tissue cultures used to grow polio viruses could possibly do the same thing. Acting on her own, she set up an experiment using cell cultures from monkey tissue. She injected the serum into hamsters and to her surprise, found that 70% of the animals developed tumors. After several more rounds of experiments, she knew that she had discovered a deadly viral contaminant in the monkey tissue cultures. Alarmed, she knew she needed to do something about it. However, when she approached her boss, Dr. Joe Smadel, with her findings, her concerns were less than welcomed.
Smadel was one of the vaccine’s staunchest defenders. At one time, after the Cutter vaccine had caused a polio outbreak, a congressional committee had considered completely withdrawing the Salk vaccine from the market. It was the “persuasiveness of Smadel’s testimony and his stature in the world of virology that convinced the panel not to cancel the vaccine program outright.” (p. 63)
Rather than praising Eddy for her discovery and demanding more NIH funding for further research, Smadel responded with intense anger. The last thing that the NIH, the federal government—and the pharmaceutical houses—wanted to hear from the DBS was information that might scare people away receiving the vaccine. Instead of being rewarded for her efforts, her discovery eventually cost her her laboratory, her staff, her position, and essentially her career as a serious investigator. This sent a chilling message to other investigators: research on the connection between SV40, cancer and the polio vaccine may be dangerous to your future.
This same message is being sent today to researchers investigating the possible connection between vaccines and autism.
Do not blame the vaccine
Dr. Andrew Wakefield is a pediatric gastroenterologist whose research at the Royal Free Hospital in London had received commendations for elegance. In 1997, he received a few calls from parents who reported their child was normal before receiving the MMR vaccine and then had subsequently lost their verbal skills and became autistic. Their symptoms included bloating, pain, diarrhea, and weight loss.
Dr Wakefield and a team of others developed a hypothesis that perhaps the measles virus in the MMR given in combination with two other live viruses was somehow damaging the gut of certain, susceptible children.
Colonoscopies were performed on 12 children who appeared to be suffering from a new form of inflammatory bowel disease, possibly triggered by the MMR vaccine. This information was published The Lancet in 1998 (Lancet 351:637-641), as merely a case report, suggesting that “further investigations are needed to examine this the syndrome [of ileolymphoid hyperplasia] and the MMR.
From that point forward, Dr. Wakefield has been villainized by the medical world. The Royal Free eventually fired him, and he has been publicly taken to task in medical journals, in media interviews and within the mainstream press on a regular basis. The heads of the UK Department of Health continue to emphasize the safety of MMR, while pouring scorn on the research of anyone who disagrees. Doctors and researchers, who insist on talking off the record with understandable caution state, ”We’ve all seen what happened to Andrew Wakefield, and we don’t want our careers destroyed.”
The definitive study: Proof that SV40 from the vaccine doesn’t cause cancer
By 1963, nearly half of the American population had received the Salk polio vaccine and the NIH’s own research had established the carcinogenicity of SV40. Confronted with a potentially disastrous public health crisis, a massive epidemiological study to assess whether SV40 was actually causing cancer in the Salk vaccine recipients needed to be done.
The daunting task fell on the shoulders of a young physician who came to work at the National Cancer Institute (NCI) Epidemiological branch in the summer of 1962. Joseph Fraumeni, MD was preparing for a career in clinical medicine when he received an offer to work for the NCI. He was hired to become the principle investigator for the office of epidemiological studies, yet by his own admission, he stated “I knew nothing about statistics or Epidemiology when I started there.” In addition, he knew frighteningly little about SV40 (p111).
With the help of biostatisticians from the NIH and the NCI, the study was designed to determine if there had been a statistically significant rise in cancer in children 6-8yo who have been vaccinated during the May and June of 1955. Three types of cancer were surveyed. The study, published in 1963 in JAMA (JAMA 185(9):713-718) concluded that “no significant alterations in mortality rates for cancer had been found and the cancer mortality rates appeared to be unaffected.” Henceforth, the Fraumeni study became landmark study that, for the next 30 years, would be quoted as conclusively proving that SV40 was a “moot issue” as a cancer-causing agent.
“Especially with the passage of time, most physicians stopped worrying that they might have harmed their patients with tainted Salk vaccine. Future generations of medical practitioners, if they learned about SV40 at all during their medical training, would find it related to them as a novel bit of medical history—an odd virus that had once contaminated the polio vaccine, but had proved to be inconsequential. Indoctrination within the medical establishment about the putative harmlessness of the virus had begun.” (from The Virus and the Vaccine, p.113-14).
Fraumeni study flaws
It was many years before the study flaws were thoroughly examined, although the study’s investigators admitted several at the outset. For example, the children were only followed for four years and certain types SV40 cancers can take many years to develop. Only cancer deaths—not cancer diagnoses—were included, meaning children diagnosed with cancer but still alive at the time of the study were excluded. Only three types of cancers were surveyed: brain, kidney and connective tissue. Therefore, other types of cancer associated with SV40—mesothelioma, bone, leukemias and lymphomas—were not included.
The most glaring flaws had to do with cohort assignment. The number of children ages 6 to 8 were estimates and an assumption was made that none of the children had moved from state to state. In addition, it was impossible to actually know who got the contaminated vaccines and who did not. Therefore, cohort assignment, the cornerstone of epidemiological research, was completely flawed. With this segment of the research flawed, the conclusions were not only highly suspect but completely inaccurate.
In spite of these blatant inaccuracies, the Fraumeni Study became “established medical fact,” definitively concluding that exposure to contaminated polio vaccine did not result in cancer. This study was quoted in every article and in every textbook, without question, for more than 30 years.
In the 1990’s, SV40 research was resumed through the work of Dr. Michele Carbone. A prestigious virologist, Carbone proved the connection between SV40 and mesothelioma, a rare cancer of the lung pleura thought mainly to be caused by asbestos. His research, published in Nature Medicine in July1997, was the first of many studies published in Italy, Germany, and the USA showing the association between SV40 and human cancers.
As his work progressed, the Viral Epidemiological Branch (VEB), a branch of the NCI, published two additional “definitive studies” meant to dissuade all residual concerns about the connection between SV40 and cancer. The first was published by Shah, Strickler and Goedert in the Journal of Infectious Dieases (J.Inf.Dis 176:1618-21, 1997). This study, subsequently referred to at the VEB Study, concluded there was “no demonstrable connection between SV40 and human cancers.” This one study became the primary weapon in the federal government’s efforts to cast doubt on the association.
Like the Fraumeni study, an analysis of the research shows that the data is inherently flawed, making the conclusions at best worthless; at worst, deceptive. The public was mislead into believing that SV40 is not a health threat. The scientific community is also mislead into believing that no further research is necessary. Wanting to form a united front, when one branch of government turns out a study that other branches champion its conclusions.
Current “definitive study”: The Danish Study
One of the most hotly contested arguments currently being debated regarding the safety of vaccines is over the presence of thimerosal in vaccines. Thimerosal, a preservative, which is 49.6% ethylmercury, a substance known to have neurotoxic effects implicated in both clinical and epidemiological studies to be associated with the exponential rise in the incidence of autism.
The government’s latest “definitive study” used repeatedly in arguments to dismiss any causality between thimerosal and autism is referred to as “The Danish study.” This epidemiologically based study was designed to examine “whether discontinuing the use of thimerosal containing vaccines led to a decrease in the incidence of autism.”
The conclusions of the study state that, “the discontinuation of thimerosal-containing vaccines in Denmark in 1992 was followed by an increase in the incidence of autism. Our ecological data do not support a correlation between thimerosal-containing vaccines and the incidence of autism.” (Pediatrics 2003;112:604–606)
The flaws continue
Similar to the Fraumeni study, an in depth analysis reveals three major flaws:
1. Autism counts [in Denmark] were first based on hospitalized, inpatient records and then changed to include outpatient records in the middle of the study.
2. Mercury levels [in the Danish studies] were substantially lower and given later than those scheduled in the U.S. in the 1990s.
3. Between 1970-92, the only childhood vaccine given in Denmark before 5 months of age was the monovalent pertussis vaccine. In the United States in the 1990s, children were exposed to multiple doses of DTP, polio, hepatitis B and haemophilus influenza B (Hib) vaccines before five months of age, all containing thimerosal. (adapted from an analysis by Mark Blaxill, Director, www.safeminds.org)
In spite of these flaws, which make the analysis of the data inconclusive, the FDA, the CDC, the American Academy of Pediatrics (AAP) and the Institutes of Medicine (IOM) all site the study as the “definitive study” that conclusively proves there is no connection between thimerosal and autism.
Knowing since the 1960s that the vaccine contained a cancer-causing virus, how did the government allow this to happen? Mostly, it evolves around the cavalier attitude within the federal agencies charged with vaccine safety.
• Division of Biological Standards in 1961 allowed contaminated lots to pass
• Taking two years to implement safety regulations requiring manufacturers to make sure vaccine was SV-40 free before inactivation
• Not issuing a recall of known-contaminated vaccine
• Not using a safer, cleaner substrate (WI-38)
• Softening of regulations to make manufacture less expensive and less time consuming
Not requiring that outdated, substandard testing be discarded for state-of-the-art PCR testing for the presence of contaminant.
No product recall for SV40-containing vaccines
In 1961, the Technical Committee on Poliomyelitis Vaccine met to discuss the safety of the existing Salk vaccine. It was concluded that “no untoward effects” had been attributed to the SV40 virus known to be in the vaccine and the virus was “assumed to be harmless.” The committee recommended no change in the current vaccination policy. Vaccinations should continue using the present stocks and until all the contaminated vaccine was used up.
“The first official health decisions had been made…there would be no recall of old vaccine containing SV40. Millions of children would continue to receive live SV40…as the nation’s polio program was simply too important to interrupt. There would be no announcement to suppliers and physicians to stop administering SV-40 contaminated vaccine. And there would be no warning to consumers that the vaccine they and their children were receiving contained a live monkey virus whose effects on humans was entirely unknown. US citizens were not going to be afforded the chance to decide for themselves whether they were willing to be exposed to SV40; the government had decided that they would.” (from The Virus and The Vaccine, p. 93.)
No product recall for thimerosal-containing vaccines
On July 7, 1999 a recommendation was made by FDA for the immediate reduction or elimination of thimerosal from infant vaccines. This announcement came after a two-year investigation, prompted by the FDA Modernization Act, which found infants may have been exposed to mercury in excess of Federal Safety Guidelines from routinely administered infant vaccines.
All members involved—including American Academy of Pediatrics (AAP), the FDA, the Centers for Disease Control (CDC) and some vaccine manufacturers—stated that they were making the recommendation to “alleviate the possible concerns” regarding thimerosal, but denied that thimerosal had a causal association with autism. The manufacturers were not ordered to remove the products currently on the market that contained thimerosal, only to create future products that were “thimerosal free.” Therefore, children continued to receive thimerosal-containing vaccines for at least two additional years.
These are only a few of the highlights found in The Virus and The Vaccine. This impeccably documented book provides the information needed to show that the mechanisms used today by government agencies and committees to ignore, diminish and dismiss concerns about vaccination are long-standing. It is no wonder that public watchdog groups, vaccine activists, and concerned parents and physicians seem to make little headway when attempting to affect the problems associated with mandatory vaccination.
Because vaccination is a part of routine healthcare for people of all ages, The Virus and The Vaccine is a “must read” for everyone. Approximately 77,500 children born each week. Every parent, faced with the decision regarding vaccination, assumes that the vaccines have been proven to be safe and the governmental agencies regulating vaccines have their best interest in mind. However, The Vaccine and the Virus documents a different truth.
However, a shift is occurring: More and more people are questioning the safety and efficacy of vaccines. The information provided in this wonderfully researched book should cause everyone—parent and healthcare providers alike—to reevaluate their trust in the vaccines, and their blind confidence in the governmental agencies who control them.