Vaccines are THOROUGHLY Tested, Both Before and After Licensure

Anti-vaccination advocates often prey on the public’s lack of knowledge of medical science and the medical literature. This is never more apparent than when the anti-vaccination advocates claim that vaccines are not well-tested before they are used. For example, many anti-vaccination advocates present the following quote:¹

“There has never been a single vaccine in this country that has ever been submitted to a controlled scientific study. They never took a group of 100 people who were candidates for a vaccine, gave 50 of them a vaccine and left the other 50 alone, and measured the outcome. And since that has never been done, that means if you want to be kind, you will call vaccines an unproven remedy. If you want to be accurate, you’ll call the people who give vaccines quacks.” –Robert S. Mendelsohn, M.D.

Now I honestly do not think that Dr. Mendelsohn actually said this, because I cannot imagine that a medical doctor could be this ignorant of his own field. Also, I have never seen a reference for this quote to something that Dr. Mendelsohn actually wrote. However, the point is clear. According to anti-vaccination advocates, vaccines are not tested before they are given to the general population.

Of course, as is the case with most of the claims made by anti-vaccination advocates, this could not be further from the truth! Before a vaccine can be licensed, it must go through several levels of controlled studies. First, it must be tested on animals. A group of animals is given the vaccine, and another group (the control group) is not. They are all then exposed to the germ that causes the disease. If the rate of the disease is significantly lower in the vaccinated animals than in the unvaccinated animals, and if there are no undesirable health effects in the vaccinated animals as compared to the unvaccinated animals, then the vaccine can be tested on human volunteers.

In the first level of human tests, a small group (usually less than 100) of volunteers are given the vaccine. If, over the next few months, there are no adverse effects noted in the small group compared to the population at large, then the vaccine can move on to the next level of clinical testing. In that level, a larger group (usually several hundred volunteers) is given the vaccine, and they are followed for up to two years. The rate of the disease in the testing group is compared to the rate for the nation as a whole. In addition, the rates of several health maladies in the testing group are compared to the rates of those maladies for the nation as a whole. If the rate of the disease is lower in the testing group as compared to the nation as a whole, and if the rates of the health maladies are no higher than the corresponding rates of the nation as a whole, then the vaccine is allowed to go to the final level of testing.

In the final level of testing, a huge group (typically several thousand) of volunteers is given the vaccine, and their health is tracked for several years. Once again, the incidence of the disease in the test group is compared to that of the nation as a whole, and the incidence of several health maladies in the test group are also compared to those of the nation as a whole. In order for the vaccine to be licensed, the rate of the disease against which the vaccine works must be significantly lower in the testing group than in the nation as a whole. In addition, the incidence of health maladies in the testing group must be no higher than that of the nation as a whole.

An example from history might help. The largest clinical study in the history of the United States was done on a vaccine. In 1954, the trial of the Salk polio vaccine was performed on 1.8 million children ². This trial was a double-blind, placebo-controlled study. In other words, half of the children got the vaccine, and the other half got the placebo. Until the end of the study, no one knew which children were which. In the end, the data indicated that the children who got the vaccine were significantly less likely to contract polio than those who got the placebo. In addition, the number of polio-unrelated illnesses were the same in the group of children who got the vaccine as compared to those who got the placebo. Thus, the vaccine was considered both safe and effective, and it was licensed for use.

In order to be licensed, every vaccine must go through not one, but at least two such trials, and that is after the vaccine has been tested on animals and tested on a small group of individuals mainly to judge its safety. Some vaccines do not make it. For example, doctors have tried to develop a vaccine against Respiratory Syncytial Virus (RSV) for years. It is one of the biggest killers of infants and young children in the U.S. There have been vaccines made, but they have never been approved for use, because the studies done on them demonstrate that they are not safe enough or effective enough to be considered a reliable medicine ^3,4.

That’s not even the end of the story. Not only must a vaccine pass through one level of animal study and three levels of human studies in order to be licensed, it is then continually monitored through the Vaccine Adverse Effects Reporting System (VAERS). This system is specifically designed to look for problems with vaccines, no matter how rare. For example, in 1999, the VAERS logged 15 serious bowel obstructions that occurred shortly after the rotavirus vaccine was administered. This frequency was quite low, since 1.5 MILLION doses of the vaccine had been given that year. Nevertheless, studies were done to see if those bowel obstructions were, in fact, related to the vaccine.

Several studies were done ⁵, and the most thorough one demonstrated that there was a slightly elevated risk of serious bowel obstructions (one case in every 11,073 children vaccinated) for those who received the vaccine. Even though the risk is rare, the severity of the bowel obstruction combined with the low mortality of rotavirus in the United States led to the decision to pull the rotavirus vaccine from the standard vaccination schedule.

So you can see that vaccines, are rigorously tested before they are licensed for use, and then once they are licensed, they are continually monitored for safety. As the American Academy of Pediatrics says, “…vaccines are one of the safest forms of medicine ever developed.”⁶ The members of this academy ought to know. They have all spent several years studying medicine at the college and post-college level, and they have devoted their careers specifically to the health of children. To ignore their expertise would be quite foolish, especially in light of the fact that those encouraging you to do so must lie in order to make their case!

REFERENCES

1. See, for example, The Pure Water Gazette or Dr. Jameson’s website (He is a popular chiropractor) or The Ptak Chiropractic Newsletter
2. Francis Jr T, et al. “An evaluation of the 1954 poliomyelitis vaccine trials: summary report.” Am J Public Health 1955; 45(suppl): 1-50.
3. Fulginiti VA, et al. “Respiratory virus immunization. A field trial of two inactivated respiratory virus vaccines: An aqueous trivalent parainfluenza virus vaccine and an alum-precipitated respiratory syncytial virus vaccine.” Am J Epidemiol 1969; 89: 435-448.
4. Chin J., Magoffin R.L., Shearer L.A., Schieble J.H., Lennette, E.H. “Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population.” Am J Epidemiol 89, 449-63 (1969)
5. Morbidity and Mortality Weekly Report, 48: 577; 1999
6. Samuel L. Katz, representing the American Academy of Pediatrics testimony before the Committee on Government Reform, U.S. House of Representatives, August 3, 1999 ( Available online)

Dr. Wile is not a medical doctor. He is a nuclear chemist. As a result, he does not dispense medical advice. He simply educates the public about scientific issues. Please consult a board-certified medical doctor before making any medical decisions for yourself or your family.

Reliable Sources of Vaccine Information

When investigating medical issues, you must be very careful what you read on the internet. Although the internet provides wonderful access to a wealth of information, it also provides access to a lot of nonsense as well. This nonsense seems to be most evident when the information is related to health. Thus, you must view the health information you read on the internet with a lot of skepticism. Check references, see what knowledgeable people say about the source, etc. etc. Lots of smart, educated people have been fooled by nonsense on the internet. Don’t allow yourself to be one of those people!

Please find below a list of websites that I find to be very reliable when it comes to vaccinations. If you are reading the nonsense put out by the anti-vaccination advocates, please at least balance your reading by investigating theses sources!

National Network for Immunization Information
This site is dedicated to providing “…up-to-date, science-based information to healthcare professionals, the media, policy makers, and the public – everyone who needs to know the facts about immunization.” Its steering committee is made up of medical doctors and Registered Nurses.

CDC’s Immunization Page
This site is made by the experts. The CDC has access to most of the data related to infectious diseases, and they monitor the safety and efficacy of vaccines. If you want facts regarding vaccines, you have to go here.

The Johns Hopkins Institute for Vaccine Safety
One of the greatest names in medicine is the Johns Hopkins Medical school. They are always on the cutting edge of medicine. The mission of this site is to “…provide an independent assessment of vaccines and vaccine safety to help guide decision makers and educate physicians, the public and the media about key issues surrounding the safety of vaccines. The institute’s goal is to work toward preventing disease using the safest vaccines possible.”

The World Health Organization’s site on Vaccines, Immunizations, and Biologicals
This is the organization that destroyed smallpox and is on its way to destroying polio. If you want to get a worldwide perspective on vaccines, this is the place to go!

Quackwatch
This website is operated by retired psychologist Dr. Stephen Barrett, MD. He chronicles all manner of quackery in regards to medicine, including the anti-vaccination movement. This is a great resource if you want to see what the data say about a host of medical issues such as vaccinations, homeopathy, anti-aging programs, etc. He even analyzes statements used in advertisements for health products. It is an invaluable resource.

A Small List of the Lies Told by the Anti-Vaccination Movement

One of the first things that struck me when I began reading the anti-vaccination literature is the large amount of deceit that is employed by anti-vaccination advocates. To combat that deceit, I have compiled a list of the many lies told by the anti-vaccination advocates.

The low rate of childhood diseases are the result of better sanitation and living conditions, not vaccines.
When outbreaks occur, the vaccinated children are the most susceptible to infection.
Vaccines are not adequately tested.
The Pharmaceutical Companies Control the Scientific Research on Medicines.
Vaccines are recommended by doctors because of the financial interests of the pharmaceutical companies.
Vaccines cause Autism.
Vaccines cause Sudden Infant Death Syndrome.
Vaccines cause Multiple Sclerosis.
Vaccines contain fetal tissue.
Vaccines suppress the immune system.
Serious conditions reported to the Vaccine Adverse Effects Reporting System (VAERS) are vaccine-related.

Anti-Vaccination Advocates Use Statistics to Lie

One common statement used in anti-vaccination literature is that when outbreaks of vaccine-preventable diseases occur, the majority of those infected turn out to be vaccinated children. ¹ According to the anti-vaccination advocates, this shows that vaccines are not at all effective at preventing the disease. The problem is that the statistic quoted actually demonstrates exactly the opposite. You see, the problem with the statistic as quoted by the anti-vaccination advocates is that the vast majority of children are vaccinated. Thus, even if only a tiny percentage of vaccinated children get the disease, their numbers will be larger than the number of unvaccinated children who get the disease.

The best way to illustrate this is to think of an example. Suppose a measles outbreak occurs in a school that has a population of 1,000. About 98% of those students (980) will be vaccinated. That leaves 20 that are not vaccinated. Now, suppose that only 2% of the vaccinated population contracts measles. That means about 20 vaccinated students will get the disease. Next, suppose that 90% of the unvaccinated children contract measles. That means 18 of the unvaccinated students will get the disease. Thus, of those who got the disease, 53% were vaccinated, and 47% were not. Does this mean that the vaccines did not work? Quite the opposite! While only a tiny minority of the vaccinated students got the disease, the vast majority of the unvaccinated students got the disease. Being vaccinated made you only 2% likely to get the disease, while not being vaccinated made you 90% likely to get the disease! Clearly, then, the vaccine was quite effective, as vaccinated students were 45 times less likely to be infected than unvaccinated students.

When comparing one group to another, then, you must make sure to take into account that one population might be greater in number than the other. Anyone with a modicum of training in research or statistics know this. Thus, in the medical literature, statistics are always reported in this way. If you look at studies that have been done on measles outbreaks, for example, you will find that the research indicates that vaccinated children are up to 35 times less likely to catch measles than unvaccinated children.² This is the proper way to report such a statistic.

The question is, since the statistics are always discussed properly in the medical journals, why do anti-vaccination advocates misquote them in their literature? They must look at the studies, or they could not get the numbers. Why, then, do they ignore the proper way to quote the statistic and instead use a deceptive way? I think that the answer is obvious: quoting the statistic the proper way will hurt their cause, while quoting them in a deceptive manner will help fool the general public into accepting their ideas.

References

1. Neil Z. Miller, Vaccines: Are They Safe And Effective, New Atlantean Press, 2002, p. 29
2. Salmon DA, et al. “Health Consequences of Religious and Philosophical Exemptions From Immunization Laws: Individual and Societal Risk of Measles” JAMA, 1999; 282:47-53

The Continuing History of Poliomyelitis

Infantile Paralysis. This sinister name was given to a disease which was virtually unheard-of before the late 19th century, but which began terrorizing developing countries and swept across the world. Many believe it has existed for centuries. In Trial by Fury: the Polio Vaccine Controversy, Aaron Klein includes a picture of a mural in Egypt which some believe shows an early victim of the disease – a priest with a withered leg.¹ Other theories as to its origin abound, but its imprint is undeniable in the histories of Western countries (and eventually the world) throughout the 20th century. This disease is now better known as poliomyelitis.

The long-standing scientific explanation for the sudden spike in polio case levels in the early 1900s states that increased sanitation actually encouraged the spread of the disease. In the “dirtier” days of the past, many were exposed to the virus throughout their lives and they developed immunity to it because they were exposed to small amounts without getting paralytic cases of it ². In addition, some of the mother’s antibodies against polio were passed on to her infant (through breast milk) so that infants were protected during the earliest months of their lives. Since most of the community was immune, when someone did get paralytic polio, it did not spread very far until the chain of immunity was broken in developing countries. As better sanitation practices provided cleaner water, among other things, many in the population were no longer immunized through low-level exposure. Now epidemics arose at alarming rates, particularly during the summer months when more children were likely to be in close proximity to each other (and the virus) for long periods of time. The World Health Organization’s Global Polio Eradication Initiative has estimated that there were 50 million worldwide paralytic polio survivors in the 20th century alone ³.

The workings of polio as a disease were not known for many years. Slowly, scientists began to learn that the virus enters through the mouth and travels to the intestines where it begins to multiply for anywhere from 4-35 days. “The initial symptoms include fever, fatigue, headaches, vomiting, constipation (or less commonly diarrhea), stiffness in the neck, and pain in the limbs.”⁴ From the intestines, the virus moves to the bloodstream and eventually invades the central nervous system through nerve fibers. It begins to destroy the motor neurons, thus immobilizing muscles and causing the characteristic paralysis of severe cases. Usually the paralysis only affects the legs, but for some it causes quadriplegia and even death by asphyxiation when the paralysis affects the portions of the brain that control breathing. Researchers today know that only 1 in 200 cases is paralytic and 5-10% of paralytic cases result in death. However, there is still no cure for the disease; it can only be prevented ⁵. Those who do contract it can be given physical therapy, but little else can be done for them.⁶

When the disease was first recognized, the medical community had no idea how to handle it. Of those who contracted the disease, not all got severe cases of it. A few had temporary paralysis but for most who experienced any kind of paralysis, it was permanent. The iron lung (an artificial means of respiratory support) and leg and arm braces became symbols of the disease’s more severe effects and the valiant efforts to aid in the suffering. Doctors were unsure of how to treat it and tried any number of things. One famous woman, Sister Elizabeth Kenny, began a clinic and treated patients by placing heat packs on their atrophied muscles and slowly working patients up to increased levels of mobility, attempting to wean them from the use of the iron lung. Many treatments were painful, and the suffering of those children stirred the hearts of researches and housewives alike. In the United States, the National Foundation for Infantile Paralysis, otherwise known as the March of Dimes, began a massive campaign to raise funds not only for sufferers and their families (who lived before the time of medical insurance), but more importantly to find a cure.

Early vaccination attempts in the 1930s were disastrous – either the vaccines were too weak to sustain immunity or they were so strong that they induced full-blown polio. At first, researchers did not know that there were three different (but closely related) viruses that caused the disease, and several vaccines came out that protected against one but not all of those viruses. Two researches in the early 1950s emerged with competing ideas of which kind of vaccine would work. Jonas Salk insisted that a killed vaccine, which used killed samples of the three major types of the poliovirus, was safe and effective. Alfred Sabin insisted that a live attenuated vaccine (which means that the virus injected is alive but a weakened form of the poliovirus) was the only one that could induce lasting immunity.

The March of Dimes funded them both, and it became a sort of race to see who would succeed first. Jonas Salk took an early lead and perfected his vaccine in 1952. He first tried it out on residents of a rehabilitation hospital for polio victims in order to see if the vaccine did, indeed, increase the antibodies in the blood against all three types of poliovirus. This seemed a safe testing ground since all of the patients had been exposed to the virus, but not all had been exposed to all three strains, thus the results offered him some idea of the vaccine’s effectiveness. When that was successful, he vaccinated his entire laboratory, himself, and his family and began testing the vaccine on other uninfected children. Finally, he decided to try a large-scale trial of the vaccine in 1954. Dr. Thomas Francis, an epidemiologist at the University of Michigan agreed to supervise the national field trial. He insisted that it be conducted as a double-blind, placebo-controlled trial. Half of the children received the vaccine and half did not, and neither the doctors, the patients, nor Salk himself knew which child got which. All of the records and later surveillance information about each child was shipped to him at the Vaccine Evaluation Center he created in Ann Arbor, Michigan. The results of this, the largest field trial in the history of the United States in which 1.8 million children participated, were released in spring of 1955: the group of children who got the vaccine were significantly less likely to contract polio than were the group of children who did not get the vaccine. In addition, the incidence of diseases not related to polio were the same between the two groups of children. As a result, the vaccine was licensed in time for the summer of 1955.⁷ Immediately, the number of polio cases in the United States plummeted (see graph in “Vaccines are Incredibly Effective at Preventing Disease”).

Not long afterward, Alfred Sabin refined his live attenuated formula, but he could not test the vaccine in the United States since so many had already been immunized using Salk’s vaccine, so he went instead to Russia to find new case subjects. Since vaccination had not begun there, polio was still raging. There (and in Singapore, Eastern Europe and Mexico), he vaccinated 4,500,000 people. There were very few side effects, and the vaccine was highly effective. After a few more tests, the United States licensed the vaccine for use in 1961, and it quickly replaced the Salk formula until 1999. Soon after licensure in the United States, the Sabin formula was proven to have caused extremely rare cases of paralytic polio ⁸. Since at that point, the threat of wild poliovirus was much greater than the threat of Vaccine Associated Paralytic Polio (VAPP), authorities continued to administrate it. By 1999, the United States had been free of wild polio for many years and the problem of VAPP was deemed to be more problematic than continuing with the Sabin formula. Since the Salk formula has no history of VAPP, it is considered safer for the general public and almost as effective ⁹, so that is what we use today in the United States.

Eventually, most countries switched over to the Sabin formula, and it is still the vaccine of choice for the World Health Organization’s Global Polio Eradication Initiative for several reasons. Not only does this vaccine, now called the Oral Polio Vaccine (OPV), provide antibody immunity from all three strains of poliovirus, but it also creates a local immunity in the intestines, the most important site for the multiplication of the virus in its early stages. Another advantage is its oral distribution which reduces the need for trained health professionals to administer it. It is very inexpensive, with each dose costing around $0.08 (US). Lastly, the OPV-vaccinated person sheds the attenuated virus through his stool, and in areas of poorer hygiene, this means that others around him will be immunized as well. The person vaccinated with the killed virus vaccine (IPV) can still be infected with polio and have it multiply in his gut since IPV does not provide that local immunity. This has become a concern of the eradication program, since circulating vaccine-derived poliovirus can still cause polio in areas where polio is no longer endemic (meaning no longer indigenous to the area). For this reason, the WHO has recommended that countries use OPV for outbreaks especially and that routine vaccination continues to be practiced until global eradication of the virus is confirmed ¹⁰. The history of polio in this country and abroad is very different from those of many other diseases.

Because sanitation reduces a population’s immunity to the disease, it first began in the very places that were equipped to fight it – developing countries with the scientific and financial means to research and develop a vaccine. Yet politics and science had to work hand-in-hand to overcome the disease, and since the two have often clashed, it was not an easy battle. Now, a little over a century after the first epidemics cropped up, the world is very nearly polio free, thanks to mass vaccination. Perhaps this disease will someday be as powerless to harm as it was for so many centuries before it was recognized.

References

1. Aaron E. Klein Trial by Fury: the Polio Vaccine Controversy Scribner (New York, NY) 1972, p. xiv (picture)
2. Center for Disease Control (CDC) “Polio Vaccines” (Available online)
3. Global Polio Eradication Initiative (GPEI) “News and Documents: Fact sheet and FAQ” ( Available online )
4. Global Polio Eradication Initiative (GPEI) “Background: The Disease and Virus” ( Available online )
5. GPEI, News
6. GPEI, Disease
7. Aaron E. Klein, pp. 79-80
8. Ibid., pp. 149-151
9. CDC, p. 4
10. Global Polio Eradication Initiative “Post Eradication Recommendations” ( Available online )

Erica A. Sommerville is not a medical doctor but a college student. She does not dispense medical advice. Her aim is to educate the public about scientific issues. Please consult a board-certified medical doctor before making any medical decisions for yourself or your family.

Vaccines DO NOT Suppress the Immune System

If a parent follows the suggested vaccination schedule ¹, it might seem to the parent that the child is getting am inordinately large number of shots. Many anti-vaccination advocates prey on the fact that most parents are not informed enough to know what is “too much” when it comes to medicine, and they say that this large number of vaccines “overwhelms” the baby’s immune system. Of course, as is the case with most assertions in the anti-vaccination camp, this assertion does not stand up to the data.

Probably the most direct study on this comes from Paul A. Offit and others ². The data analyzed by these authors indicate the following:

Newborns are capable of mounting an immune response at birth. This goes counter to what some anti-vaccination advocates claim, but is nevertheless supported by the data. Of course, any Christian should immediately realize that this is the case. God would certainly design an immune system that was able to respond the moment a baby left the protection of his or her mother’s womb. Anything less would simply be shoddy workmanship!
Mild illness at the time of vaccination does not affect the level of antibodies produced by vaccination. Many who are fooled by the anti-vaccination advocates don’t even realize that we can chemically measure a body’s immune response to a vaccine (or to an infection) by actually measuring the level of antibodies produced in the blood. These antibodies are so well- characterized that we can actually determine which antibody fights which disease. Even though a child might be mildly sick (and thus his or her immune system is fighting off an infection), the child’s immune system makes the same level of antibodies in response to a vaccine as it would if the child were not at all sick. This indicates that God’s wonderfully designed immune system is not easily “overwhelmed!”
When comparing children who are given just one vaccine to children who are given several, there is no difference between the level of antibodies produced. In other words, multiple vaccines do not “fight” each other for attention from the immune system. Whether a child gets one vaccination or several, the level of immune response is the same for each disease. If multiple vaccines “overwhelmed” a child’s immune system, you would see the immune response for each disease decrease as the number of vaccinations increase. This is simply not the case.

Another important study comes from Otto and others ³. This study investigated 496 vaccinated and unvaccinated children, comparing the health of the vaccinated children to that of the unvaccinated children. It found that children who received immunizations against diphtheria, pertussis, tetanus, Hib, and polio within the first 3 months of life had fewer infections than those who did not. Surprisingly enough, even the rates of infections unrelated to the vaccines were lower in the vaccinated group than in the unvaccinated group. Now, if vaccines really did “overwhelm” these babies’ immune systems, we would see the vaccinated group have a higher rate of infections as compared to the unvaccinated group. Instead, we see precisely the opposite, indicating that vaccines do not overwhelm an infant’s immune system.

For more information on the safety of vaccines, see our article entitled Vaccines are Very Safe.

References

1. Recommended Childhood and Adolescent Immunization Schedule
2. Paul A. Offit, et al. “Addressing Parents’ Concerns: Do Multiple Vaccines Overwhelm or Weaken the Infant’s Immune System?” Pediatrics Vol. 109 No. 1 2002; pp. 124-129
3. Otto S, et al. “General non-specific morbidity is reduced after vaccination within the third month of life-the Greifswald study.” J Infect. 2000; 41:172-175

More Examples of The Effectiveness of Vaccines

The history of rubella in the United States gives another excellent example of how disease rates plummet when vaccination occurs. The following graph shows rubella cases from 1966 (the first year rubella was a nationally notifiable disease) to 2001:¹

Notice that the incidence of rubella did not begin to fall until the vaccine was licensed in 1969. The greatest decrease came after the second (combination) vaccine, the MMR, was licensed. Notice also that the decrease in the rubella rate started in about 1970. Remember from the previous graphs of polio and measles that the significant decrease in the measles rate started in 1964, while the significant decrease in the polio rate started in 1955. This makes it obvious that improved sanitation is not the reason that these diseases declined. If improved sanitation were the explanation, the diseases should all decline at roughly the same time, not spread out over a period of 15 years!

The trend that I have shown for polio, measles, and rubella exists in other countries for other diseases as well. For example, the UK’s department of health has tracked the case rates (and death rates) of many diseases in the UK. Their data also show the dramatic efficacy of vaccines. Click on the links to see the dramatic decline in these diseases in the UK, thanks to immunization:

Diphtheria Rate plummeted in 1944, just after diphtheria immunization was introduced

Measles Rate plummeted in 1968, just after measles immunization was introduced

The conclusion should be clear – disease rates plummet once vaccination is introduced.

References

1. Morbidity and Mortality Weekly Report, Volume 42:#53 (1994),p. 95 Volume 50:#53 (2003), p. 119

Dr. Wile and Erica A. Sommerville are not medical doctors. Dr. Wile is a nuclear chemist, and Miss Sommerville is a college student. As a result, they do not dispense medical advice. They simply educate the public about scientific issues. Please consult a board-certified medical doctor before making any medical decisions for yourself or your family.

Vaccines Actually Protect Against Sudden Infant Death Syndrome (SIDS)

For quite some time now, anti-vaccination advocates have tried to link vaccination to Sudden Infant Death syndrome (SIDS). In her book, Vaccination: 100 Years of Orthodox Research shows that Vaccines Represent a Medical Assault on the Immune System, Dr. Viera Scheibner, Ph.D., makes the outlandish claim that when the pertussis vaccination age was moved from 3 months old to 2 years old in Japan (1975), the phenomenon of SIDS (which she calls “cot death”) vanished. Here are a couple of quotes from her book:

“In 1975 Japan raised the minimum vaccination age to two years; this was followed by the virtual disappearance of cot death and infantile convulsions.”¹

“The most important lesson from the Japanese experience is that when the vaccination age was moved to two years, the entity of cot death disappeared.”²

These claims are absolutely false, but they have been repeated over and over again by anti-vaccination advocates ³.

How do we know that they are false? Because a study ⁴ was done on the autopsy records of infants (aged 1 week to 1 year old) who died in the Tokyo area. This study found that the number of SIDS cases rose continually from 1975 through 1993, the last year that the study considered. In fact, from 1979 to 1993, the number of SIDS cases in the Tokyo region increased by more than a factor of 12 ⁵! Clearly, then, SIDS did not disappear from Japan once the vaccination age was raised. In fact, it increased considerably.

Why did it increase considerably? Most likely, it was because the number of forensic pathologists who began recognizing the phenomenon of SIDS increased, not because the actual rate of SIDS increased. In Japan, an unexpected death is identified by the broad term “Sudden Unexpected Death” (SUD). From 1974 through 1993, the SUD rate for infants in the Tokyo area was shaky, but fairly steady, averaging about 30 cases per year ⁶. Thus, the number of infants dying unexpectedly was fairly constant. However, the number of those cases recognized as SIDS rose significantly during the same time period. Most likely, then, it was the diagnosis of SIDS that increased, not the actual rate of SIDS.

The point, however, is quite clear. The SIDS rate in Japan either increased or stayed the same after the vaccination age was raised. It did not lower, much less disappear. Thus, the statement that Dr. Scheibner makes in her book is a lie, and that lie has been repeated over and over again. How in the world could Dr. Scheibner make such an outrageous claim and be believed? Because she referenced her claim to two studies ^7-8, and those who repeat her claim have obviously not checked those references.

If you bother to check her references, you will see that neither of them make any claim regarding the number of SIDS cases in Japan. Instead, they reference the number of claims made to Japan’s vaccine injury compensation program. Much like the United States’ vaccine injury compensation program, Japan offers a program whereby people who think that their child has been injured by a vaccine can apply for compensation. Their claim is reviewed, and if there seems to be any plausible link to the vaccine, the claim is paid. The two articles that Dr. Scheibner references say that the number of SIDS claims to the vaccination compensation program declined to zero once the vaccination age was raised to 2 years. Of course, that would logically have to happen, since SIDS is defined as occurring in children age 1 year or younger. Since no one of that age could get the vaccine anymore, it would be impossible for someone to make a SIDS claim to the vaccine injury compensation program!

So you see that one of the most popular claims made by anti-vaccination advocates is (as usual) untrue, and it has survived only because people who read the claim do not bother to check the references! As is the case with many anti-vaccination claims, a quick check of the medical literature simply destroys the claim entirely.

Not only does the supposed “demonstration” of a link between SIDS and pertussis vaccination in Japan not stand up to scrutiny, a cursory review of the medical literature provides many detailed studies that show that the rate of SIDS amongst unvaccinated children is actually higher than the rate of SIDS amongst vaccinated children! For example, Hoffman and others ⁹ studied SIDS victims using data from the National Institute of Child Health and Human Development. In their study, they compared 757 SIDS cases to 1,514 living control children. The control children were matched to the SIDS cases based on age, race, and low birth weight. According to their results, the living children were 1.3 times more likely to have been immunized compared to the children who died of SIDS. In other words, according to this study, if a child was not vaccinated, he or she was more likely to die of SIDS than if the child were vaccinated!

Although that might sound like a surprising conclusion if you have been reading the anti-vaccination literature, you will find that it is the common conclusion in the medical literature. For example, another study by Walker and others ¹⁰ focused on healthy babies with birth weights greater than 5.5 pounds. For these children, unvaccinated children were 6.5 times more likely to die of SIDS than were vaccinated children.

Why does vaccination actually provide a protective effect against SIDS? According to a biochemical study by Essery and others ¹¹, it is most likely due to the fact that the DPT vaccine produces antibodies that are cross-reactive to staphylococcal toxins, which are found in many SIDS cases. In other words, the study found that the antibodies produced by the DPT vaccine are able to fight the toxins produced in staph infections! Thus, the DPT vaccine not only protects the infant from diphtheria, pertussis, and tetanus, it also offers some protection against SIDS (or at least staph infection)!

So once again we see that the medical literature not only invalidates the claims of anti-vaccination advocates, it actually indicates that by opposing the DPT vaccine, anti-vaccination advocates are actually increasing the incidence of SIDS (along with the incidence of pertussis, diphtheria, and tetanus). This serves once again to illustrate the danger of listening to the anti-vaccination movement.

References

1. Scheibner V. Vaccination: 100 Years of Orthodox Research shows that Vaccines Represent a Medical assault on the Immune System New Atlantean Pr, 1993, p. xix
2. Ibid, p. 49
3. See, for example, ( Richard Lanigan’s site) or ( Mercola’s website)
4. Funayama M., et al. “Autopsy cases of sudden unexpected infant deaths examined at the Tokyo medical examiner’s office, 1964-1993” Am J Forensic Med Pathol. 1996;17(1):32-7
5. Ibid, p. 33
6. Ibid
7. Cherry J.D., et al. “Report of the Task Force on Pertussis and Pertussis Immunisation – 1988” Pediatrics 1988; 81 (suppl): 939-84
8. Noble G.R., et al. “Acellular and Whole-Cell Pertussis Vaccines in Japan: Report of a Visit by US Scientists” JAMA 1987; 257(10): 1351-6
9. Hoffman H.J., et al. “Diphtheria-tetanus-pertussis immunization and sudden infant death: results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome risk factors” Pediatrics 1987;79(4):598-611
10. Walker, A.M., et al. “Diphtheria-tetanus-pertussis immunization and sudden infant death syndrome” Am. J. Public Health 1987;77:945-951
11. Essery S.D., et al. “The protective effect of immunisation against diphtheria, pertussis and tetanus (DPT) in relation to sudden infant death syndrome” Am. J. Public Health 1999;25:183-92

Dr. Wile is not medical a doctor. He is a nuclear chemist. As a result, he does not dispense medical advice. He simply educates the public about scientific issues. Please consult a board-certified medical doctor before making any medical decisions for yourself or your family.

Vaccines are Incredibly Effective at Preventing Disease

Dr. Lewis Thomas, in his book, Lives of a Cell: Notes of a Biology Watcher, says that the best kind of medical technology is, “…the kind that is so effective that it seems to attract the least public notice; it has come to be taken for granted. This is the genuinely decisive technology of modern medicine, exemplified best by the modern methods for immunization against diphtheria, pertussis, and the childhood virus diseases.”¹ Indeed, over the years, vaccines have become so effective at eliminating disease that they have become taken for granted. So much so that there is a growing movement trying to claim that vaccines do not even help to prevent disease. Nothing could be further from the truth! Vaccines have saved the lives of countless children and adults over the years, and anyone who truly cares for children cannot ignore this rock-solid fact.

There are three main ways that we want to demonstrate the efficacy of vaccines. First, we want to show you the historical data that demonstrate how disease rates fell dramatically as a result of mass immunization. Second, we want to discuss some of the detailed, controlled studies that demonstrate that people are significantly less likely to be infected by a disease against which they have been vaccinated as compared to those who have not been vaccinated. Finally, we want to discuss the devastation that occurs when vaccination rates drop in a population.

Let’s start with the historical data. Below, you will find two graphs showing you the polio and measles rates in the United States from 1944 to 2001:²

There are several important things to notice regarding these graphs. First, notice that in the case of polio, disease rate rose in a shaky but steady fashion from 1944 to 1952. Then, there was a slight (34%) decrease in the disease rate from 1953 to 1955. However, from 1955 to 1957, there was a dramatic decrease (80%) in the disease rate. What explains these drops in disease rate? Well, notice that the first polio vaccine was licensed in 1955. The dramatic decrease in disease rates, then, came right after the polio vaccine was licensed. What about the smaller decrease from 1953 to 1955? Well, Salk developed his vaccine in 1952 and began testing it. For example, in 1954, the Salk vaccine was tested in a double-blind study of 1.8 million children ³. Thus, the benefits of the vaccine are apparent even in the testing phase!

Now look at the graph for measles. Once again, the story is similar. There is not nearly as much of a rise in the measles rate in the early years (1944-1958), but the disease rate follows the typical shaky pattern of epidemic cycles that is often seen in infectious disease rates. However, once again, there is slight decrease in the disease rate just prior to the licensing of the vaccine (during the testing phase), and then a dramatic decrease in the disease rate after the licensing of the vaccine.

Do these graphs demonstrate conclusively that the polio and measles vaccines stopped these dreaded diseases? Of course not. After all, this could all be explained by an amazing coincidence. Perhaps something else stopped each of these diseases, and that “something” just happened to occur during the testing and licensing phases of the vaccine. However, it does add some evidence to the pile. If you truly want to believe that vaccines are not effective, you have to believe in a couple of amazing coincidences in order to explain this data. Of course, this is not the only data available. We can look at other diseases whose infection rates dropped dramatically after the vaccine was introduced. Thus, the number of coincidences in which you must believe (if you think that vaccines are not effective) just keeps increasing!

There is one other very important thing to note from the graphs. Anti-vaccination advocates often try to explain the dramatic decrease in vaccine-preventable diseases in terms of increased sanitation. They say that these disease rates are so low because we have developed better sanitary practices over the years. However, these graphs show that this is just not true. After all, the polio disease rates decreased dramatically in the late 1950s. However, the measles rates did not decrease dramatically for another 10 years. If good sanitary practices were responsible for the drop in disease rates, you should see the disease rates fall roughly at the same time. That’s just not the case. The disease rates fell only when vaccines were tested and then approved. Also, note the short time over which the disease rates fell so dramatically. Do sanitation practices change so quickly that they completely “clean up” a country in a matter of a few years? Definitely not! Improved sanitation just does not explain the data.

In fact, most medical historians blame increased sanitation for the rise in polio from 1944 to 1952. When sanitary practices were rather poor, people were regularly exposed to small amounts of the polio virus, usually when they were babies and therefore had the extra protection given to them by the antibodies they received through their mothers’ milk. Their immune systems were able to conquer the weak exposure to the virus with the help of their mothers’ antibodies, and thus they became immune. As a result, the poor sanitation was actually acting like a “dirty” vaccine! As sanitary practices improved, fewer people were exposed to small amounts of the virus as infants. As a result, when they were exposed to concentrated amounts of the virus (from a person who already had the disease, for example), they would succumb to the disease ⁴. Note that this makes sense in the light of the data, because the rise in the polio rate occurred slowly, which is what you expect when sanitation is playing a role.

Although these graphs are very effective illustrations of the power of vaccines, as we stated before, they are not definitive evidence. After all, coincidences could explain the graphs. By far, the best evidence of how effective vaccines are comes from controlled studies. In these studies, vaccinated people are compared directly to unvaccinated people, and the results are astounding.

For example, Feikin and others studied all measles and pertussis cases among children (age 3-18) in Colorado from 1987 to 1988 ⁵. When they compared the vaccinated children to the unvaccinated children, they found that vaccinated children were 22.2 times less likely to contract measles than were the unvaccinated children. In the same way, vaccinated children were 5.9 times less likely to contract pertussis than were unvaccinated children. In other words, according to this study, if you do not vaccinate your children, you have increased their risk of getting measles by 2,220%, and you have increased their risk of getting pertussis by 590%!

Another finding from this study is that schools in which outbreaks occur have 2.9 times the percentage of unvaccinated students as do schools in which outbreaks do not occur. Thus, this study tells us that those who do not vaccinate their children are not only putting their own children in danger, but they are also putting other people’s children in danger, because the larger the number of unvaccinated children in a group setting, the more likely an outbreak is to occur.

Another study by Salmon and others was even more comprehensive but focused only on measles. They studied measles cases over seven years (1985-1992) using the Center for Disease Control’s Measles Surveillance System ⁶. In their study, they found that vaccinated children (ages 5-19) were 35 times less likely to contract measles than were unvaccinated children. Another important result of their study was that the general measles outbreak that was seen in 1991 (note the small bump at 1991 in the measles graph above) actually started a year earlier among the unvaccinated population. In other words, that outbreak was most likely started by the unvaccinated population! This is another example of parents that do not vaccinate actually putting everyone’s children at risk.

These kinds of studies are done on all vaccines, and the results are just as stunning. In a double- blind, placebo-controlled trial of the flu vaccine, for example, 1,602 children were given a flu vaccine or placebo. Vaccinated children were 13.6 times less likely to catch the flu than those who got the placebo ⁷. That study was expanded to a second year for 1,358 of the children and, in addition, 4,561 adults were added to the study. Once again, those who received the flu vaccine were many times less likely to get flu than those who received the placebo ⁸. Even in the elderly, the flu vaccine is very effective at preventing illness. According to a meta-analysis done on flu-related data in seniors, the flu vaccine reduced mortality rates in people 65 years and older by 50%⁹.

We could go on and on, but the results are quite clear. When vaccinated people are compared to unvaccinated people, the vaccinated ones are significantly less likely to contract the disease than the unvaccinated ones. Thus, controlled studies clearly show that vaccines are quite effective.

A particularly sad way of illustrating the effectiveness of vaccines is to see what happens when vaccination rates in a population are low. Consider, for example, the following graphs of pertussis rates in the United Kingdom ¹⁰:

The graph on the left shows the number of pertussis cases in the UK per year along with the number of pertussis deaths per year (multiplied by 60 so that you can see them on the graph) from 1940-1997. Notice that the disease rate is steady but shaky (as is typical for infectious diseases) until mass immunization begins. As vaccination becomes standard practice, the disease rate decreases.

Now look at the graph on the right. This graph contains the same data (pertussis cases and pertussis deaths – this time multiplied by 700) along with the pertussis vaccination rate from 1966 to 1997. Notice what happened in 1972-1973. The vaccination rate began to decline. This was caused primarily by anti-vaccination advocates who made claims that the pertussis vaccine was linked to devastating side effects such as SIDS. (Detailed, controlled studies show that the DPT vaccine actually lowers a child’s risk of SIDS ^11-13). Notice what happened as the vaccination rate went down – the disease rate went up. This kind of data is nearly impossible to explain if you think that vaccines are not effective. Clearly there was no appreciable difference in sanitation, nutrition, etc. during the1970’s. Nevertheless, that period saw an increase in the number of pertussis cases, and it coincides perfectly with a lowering of the vaccination rate. Then, once the vaccination rate increased again, the disease rate decreased in kind.

While looking at graphs like the one above is very instructive, it is important to note that these data are more than just numbers. They represent innocent children who suffered (and sometimes died) because their parents (or others who were in charge) were fooled by anti-vaccination advocates. The death of any child is tragic, but it is doubly so when it could have easily been prevented through vaccination. If you would like to learn more about the ravages induced on innocent children by the anti-vaccination movement, please see our discussion entitled, Small Decision, Large Impact: Why Not Vaccinating Your Child Is Dangerous or Individuals Who Have Suffered or Died Because They Were Not Vaccinated.

We need to make one more point before we finish this discussion. Anti-vaccination advocates are adept at coloring the facts to suit their agenda (see, for example, Anti-Vaccination Advocates Use Statistics to Lie). Often, anti- vaccination advocates quote death rates from disease and state that the death rates due to diseases like pertussis were declining long before the vaccine was introduced, and this shows that the vaccine is not necessary in combating the disease. However, as is typical, the anti-vaccine advocates who make such statements are either showing their ignorance of medicine or willfully lying.

Even a first-year medical student knows that you cannot track a disease with its death rate. This is because modern medicine learns how to treat the symptoms of a disease before it learns how to treat the disease itself. As a result, the death rate from a disease regularly decreases once the disease has been characterized, even though the number of people catching the disease is constant or increasing. You can see that from the left-hand figure above. From 1940 to 1953, the average pertussis rate in the UK stayed rather steady, while the death rate dropped quickly. This is simply because doctors were treating the symptoms of the disease well, allowing those who contracted it to live longer.

To properly track the prevalence of a disease, then, you must look at the disease rate, not the death rate. This is important for two reasons. First, the disease rate tells you the prevalence of the disease itself, and it is not affected by the ability of doctors to treat the symptoms of the disease. Second, by monitoring only the death rate, you are ignoring the devastating long-term health consequences (deafness, blindness, paralysis, etc.) that accompanies many cases of childhood disease. Many of those who actually survive diseases such as pertussis are faced with a life-long disability that resulted from contracting the disease. These children are not accounted for in a study of the death rate. Thus, the disease rate is the important indicator when tracking the prevalence of a disease, and as the data clearly show, when the vaccination rate increases, the disease rate decreases, and when the vaccination rate decreases, the disease rate increases!

The bottom line is quite simple: Whether you look at disease rates over time or detailed, controlled, scientific studies, vaccines are incredibly effective at preventing disease. There is just no other way to explain the data.

References

1. Lewis Thomas, The Lives of a Cell: Notes of a Biology Watcher, New York: Viking Press, 1974, pp. 34-35.
2. Morbidity and Mortality Weekly Report, Volume 42:#53 (1994),pp.83-88; Volume 50:#53 (2003), p. 119
3. Francis Jr T, et al. “An evaluation of the 1954 poliomyelitis vaccine trials: summary report.” Am J Public Health 1955; 45(suppl): 1-50.
4. Hileman, B. “Risk Assessment in Medical Innovation.” Chemical and Engineering News, May 5, 2003;29-34
5. Feikin DR, et al. “Individual and Community Risks of Measles and Pertussis Associated with Person Exemptions to Immunization.” JAMA, 2000; 284:3145-3150.
6. Salmon DA, et al. “Health Consequences of Religious and Philosophical Exemptions From Immunization Laws: Individual and Societal Risk of Measles.” JAMA, 1999; 282:47-53
7. Belshe RB, et al. “The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children.” N Engl J Med., 1998; 338(20):1405-12.
8. Belshe RB, et al. “Safety, efficacy and effectiveness of the influenza virus vaccine, trivalent, types A and B, live, cold-adapted (CAIV-T) in healthy children and healthy adults.” Vaccine, 2001;19(17-19):2221-6.
9. Vu T, Farish S, Jenkins M, Kelly H. “A meta-analysis of effectiveness of influenza vaccine in persons aged 65 years and over living in the community.” Vaccine, 2002;20(13-14):1831-6.
10. Data from the Public Health Laboratory Service Communicable Diseases Surveillance Centre, 61 Colindale Avenue, London NW9 5DF.
11. Hoffman H.J., et al. “Diphtheria-tetanus-pertussis immunization and sudden infant death: results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome risk factors” Pediatrics 1987;79(4):598-611
12. Walker, A.M., et al. “Diphtheria-tetanus-pertussis immunization and sudden infant death syndrome” Am. J. Public Health 1987;77:945-951
13. Essery S.D., et al. “The protective effect of immunisation against diphtheria, pertussis and tetanus (DPT) in relation to sudden infant death syndrome” Am. J. Public Health 1999;25:183-92

The Pharmaceutical Companies Do Not Control the Scientific Research on Medicines

Those who consider vaccines to be unsafe or ineffective have a serious problem when faced with the medical literature, because study after clearly shows that vaccines are both safe and effective. Of course, this is not a problem for many in the anti-vaccination movement, as they are unfamiliar with the scientific literature. However, those who are familiar with the scientific literature are forced to find some way to discount this overwhelming evidence. Thus, they often posit that the medical literature is controlled by the “evil” pharmaceutical companies. According to the theory, these pharmaceutical companies are so heavily invested in the production of medicines that they keep the bad news about vaccines from getting out, and they “rig” the studies that are published in order to make sure that vaccines come out looking good.

There are, of course, several things wrong with such an outlandish conspiracy theory. First and foremost, the vast majority of those who perform and publish the studies which appear in the medical literature are not associated in any way with any pharmaceutical company. Thus, they would have no reason to do the pharmaceutical companies’ bidding.

Second, if the pharmaceutical companies really were able to manipulate the research, they would be just as likely to “rig” the data of a study on a competitor’s product to make it look bad as they would be to “rig” a study on their product to make it look good! For example, GLAXO Smithkline makes a Hepatits A vaccine. However, it does not make an MMR vaccine. Merck and company makes both. Clearly, GLAXO Smithkline would benefit greatly if it were determined that the MMR vaccine is fatally flawed. This would cause Merck and company to lose profits, possibly putting it out of business. If that were to happen, GLAXO Smithkline would suddenly get all of the Hepatitis A vaccine business. Thus, from a business point of view, GLAXO Smithkline should “rig” the studies on the MMR vaccine. Nevertheless, we do not see these things happening.

Thirdly, you might not be familiar enough with the medical literature to know this, but studies come out regularly which are really bad for the pharmaceutical companies. Let’s start with vaccines themselves. Respiratory Syncytial Virus (RSV) is one of the biggest killers of infants and young children in the U.S. For years, pharmaceutical companies have tried to make a vaccine. If a pharmaceutical company could get an RSV vaccine licensed, it would make millions! However, one has never been approved. Why? Because the studies done on the vaccines that have been made demonstrate that they are not safe enough or effective enough to be considered a reliable medicine ^1,2.

Now if the pharmaceutical companies were able to “rig” things to make their products look good so as to cash in on the misery of the American people, why didn’t they “rig” these studies to show that the RSV vaccines were safe and effective? After all, since RSV is still a big childhood killer, they would stand to make a lot of money if they could get their vaccine licensed. Nevertheless, they are missing out on this cash cow just because of a couple of annoying studies. Why haven’t they buried those studies or “rigged” them to come out in favor of the vaccine?

Another example of how the medical literature is clearly not slanted in the pharmaceutical companies’ favor comes from studying the history of the rotavirus vaccine. In 1998, the rotavirus vaccine was licensed because it passed all levels of controlled studies required for licensure. However, in the final level of clinical study, five children of the 10,054 who received the vaccine came down with a serious bowel obstruction. Only one child of the 4,633 who did not receive the vaccine (the control group) came down with the same malady. However, the difference between five out of 10,054 and one out of 4,633 was not statistically significant, so the vaccine was licensed ³. Even though it was licensed, this serious bowel obstruction was listed as a possible side effect and was specifically flagged for surveillance once the vaccine was given to the general public.

In 1999 (just ONE YEAR later), the Vaccine Adverse Effects Reporting System (VAERS) logged 15 reported cases of the serious bowel obstruction amongst those who received the rotavirus vaccine. Even though the frequency of this side effect was low (15 out of 1.5 million doses), it generated enough concern that studies were quickly done to see if these cases were related to the vaccine.

Several studies were done ^4-5. The most thorough one demonstrated that there was a slightly elevated risk of serious bowel obstructions (one case in every 11,073 children vaccinated) for those who received the vaccine. Even though the risk is rare, the severity of the bowel obstruction combined with the low mortality of rotavirus in the United States led to the decision to pull the rotavirus vaccine from the standard vaccination schedule.

This story is illustrative in three ways. First, it shows the efficacy of the surveillance that is constantly done on vaccines. In just over one year after the licensure of the vaccine, an extremely rare side effect was reported, analyzed, and was serious enough to outweigh the benefits of the vaccine. As a result, the vaccine was pulled from the vaccination schedule. Second, it shows the risk/benefit analysis that is important for any medicine. The rotavirus vaccine was effective. It prevented the disease in many children who would have otherwise gotten it. However, the risk of death or long-term side effect from the disease is relatively low. Thus, even though this vaccine produced a benefit, that benefit was small. In addition, the medical studies clearly showed a risk that, although small, was not insignificant. Thus, the data indicated that on balance, children were probably more at risk getting the vaccine than not getting the vaccine, so the vaccine was pulled from the standard vaccination schedule. This is the kind of solid, medical reasoning that must be used when evaluating any medicine, including a vaccine.

Finally, this story clearly shows that the pharmaceutical companies do not manipulate the scientific studies. Even the studies done for licensure noted the problem. Those studies suggested surveillance after the vaccine was given to the general public. Thus, the pharmaceutical company did not “hide” the problem. In fact, they made sure that the problem was well understood so that surveillance could be done. Then, when the problem began to appear on VAERS, studies were quickly done, and the studies implicated the vaccine, causing it to be pulled from the vaccination schedule.

If the pharmaceutical companies were able and willing to manipulate the studies, they certainly did not do it here, and the result was a huge loss of money! Clearly, at a rate of 1 case every 11,073 children, this problem could have been easily “swept under the rug.” However, it was not. Why? Because the scientific literature is not easily manipulated.

I want to pause here a moment and point out that this whole rotavirus vaccine issue once again shows how ignorant anti-vaccine advocates are when it comes to the medical literature. If anti-vaccine advocates were even passingly familiar with the medical research on vaccination, they would not only know about the rotavirus vaccine issue, but they would also notice that many of the same authors on the study showing a definite problem with the rotavirus vaccine are also authors of studies that show other vaccines do not have problems. For example, these authors: Destefano F, Lieu T, Black SB, Shinefield H, and Chen RT are all a part of the study that caused the rotavirus vaccine to be pulled from the market. However, they are all also on a major study that showed no connection between thimerosal-containing vaccines and autism or ADD.⁶ So could some anti-vaccination advocate please explain to me how these same authors can be “in league” with the big, bad pharmaceutical companies when it comes to thimerosal-containing vaccines, but not when it comes to the rotavirus vaccine?

Vaccine studies are not the only ones that end up being bad for the pharmaceutical companies. Studies are constantly being performed on medicines that have been licensed by the FDA. Although most of these studies end up demonstrating the safety and efficacy of the medicine studied, this is not always the case. For example, a recent study shows that Lipitor and other cholesterol-lowering drugs can cause nerve damage ⁷. Drug companies raked in more than 9 billion dollars on such drugs in the year 2000. Nevertheless, this study will reduce sales considerably, as it identifies an entire class of people who should not be taking such drugs.

Another example of a medical study that is bad for the pharmaceutical companies comes from the area of estrogen therapy. A major study was recently published which shows that estrogen therapy can have significant side effects ^8-9. This has already radically changed how doctors are prescribing the third most prescribed drug in the United States. Wyeth, a leading maker of estrogen therapy drugs, made more than 2 BILLION dollars from them in 2001. The company’s stock plunged 24% when the study’s results were announced. Wyeth itself actually informed all of the doctors in its database about the study, even though they knew it would dramatically decrease sales.¹⁰

So you see that the medical literature is decidedly not “pro-pharmaceutical company.” It is simply a forum for the publication of data. These data many times support the medicines made by the pharmaceutical companies, but sometimes they do not. It is the data, not the finances of the pharmaceutical companies, that drives the medical literature. Anyone who has dealt with the rigorous peer-review process necessary to publish in the standard medical journals knows that. However, the public does not, and anti-vaccination advocates prey on the public’s ignorance so as to cast doubt on the reliability of medical science.

References

1. Fulginiti VA, et al. “Respiratory virus immunization. A field trial of two inactivated respiratory virus vaccines: An aqueous trivalent parainfluenza virus vaccine and an alum-precipitated respiratory syncytial virus vaccine.” Am J Epidemiol 1969; 89: 435-448.
2. Chin J., Magoffin R.L., Shearer L.A., Schieble J.H., Lennette, E.H. “Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population.” Am J Epidemiol 89, 449-63 (1969)
3. Rennels M.B., Parashar U.D., Holman R.C., Le C.T., Chang H.C., Glass R.I. “Lack of an apparent association between intussusception and wild or vaccine rotavirus infection.” Pediatr Infect Dis J 1998;17:924-5
4. Kramarz P., et al., “Population-based study of rotavirus vaccination and intussusception.” Pediatr Infect Dis J. 2001 Apr;20(4):410-416
5. A good review of many of the studies: Morbidity and Mortality Weekly Report, 48: 577; 1999.
6. Verstraeten T., et. al., “Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.” Pediatrics 112:1039-48, 2003
7. Gaist D, Jeppesen U., Andersen M., Garcia Rodriguez L.A., Hallas J., Sindrup S.H. “Statins and risk of polyneuropathy: a case-control study.” Neurology 2002 May 14;58(9):1333-7.
8. Writing Group for the Women’s Health Initiative Investigators, “Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women’s Health Initiative Randomized Controlled Trial” JAMA 2002; 288:321
9. Lacey, James V. Jr, et al. “Menopausal Hormone Replacement Therapy and Risk of Ovarian Cancer” JAMA 2002; 288:334
10. Thayer, Ann “Halted Estrogen Study Hits Wyeth” Chemical and Engineering News, July 15, 2002; 8