A Case Study In How Something With Little Substantial Research Can Be Adopted As Fact

“It ain’t what you don’t know that gets you into trouble. It’s what you know for sure that just ain’t so.”- Mark Twain

“No one can see a bubble. That’s what makes it a bubble.”– The Big Short

“I cannot give any scientist of any age any better advice than this: The intensity of the conviction that a hypothesis is true has no bearing on whether it is true or not.”- Peter Medawar

If the US government and other prominent health organizations endorse a particular measure, we assume it must be scientifically based and appropriately researched. After all, they can point to research and if that research wasn’t substantial then they wouldn’t endorse it, now would they? Unfortunately, that’s not how the public health world works sometimes.

Now while we’d love to live in a world where all public health recommendations are made solely on the basis of accurate research with the health of the population in mind, and where we could see unicorns at the local zoo, both are impossibilities. The fact is that research is conducted and analyzed by human beings who have their own agendas, desires, egos, and biases, all of which sometimes carry over into the research and into subsequent recommendations based on that research. Sometimes, this means that an idea that isn’t fully substantiated makes its way into health policy. So how does this type of thing happen? Well let’s take a look at our case study: the American Heart Association’s low fat diet.

Earlier in the 20th century, the average American diet consisted of very high fat foods with a great deal of animal protein and/or sugar and very little fruits and vegetables. In some areas- especially the South- food was the accepted indulgence of choice since alcohol was considered a sin. In the 1940’s and 1950’s, research began to show that high levels of cholesterol were correlated with heart disease and some researchers began proposing that overweight Americans should decrease their fat intake. In 1977, the McGovern report instructed that Americans in general should eat more whole grains, less meat, more fruits and vegetables and substitute nonfat dairy products for whole fat ones. From Anne LaBerge’s overview of the history of the low-fat diet:

“A turning point in obesity/heart disease studies came in 1983 with the publication of an article based on the Framingham studies, which cited obesity as an independent risk factor for heart disease.21 This finding lent further support to the low-fat approach because scientists believed that the low-fat diet might not only prevent coronary heart disease, but also could promote weight loss, thereby reducing the incidence of obesity. By 1984, the scientific consensus was that the low-fat diet was appropriate not only for high-risk patients, but also as a preventive measure for everyone except babies.22 Low fat carried the day, in spite of continued serious skepticism.23 The diet-heart hypothesis remained a hypothesis, but, as if already proven, it became enshrined in federal public health policy and was promoted by health-care practitioners and the popular health media. By 1988, the Surgeon General’s report emphasized the health dangers of dietary fat, and in 2000, the federal government’s “Report on Nutrition and Health” labeled fat the unhealthiest part of the American diet. From 1984 through the 1990s, dietary fat was increasingly blamed not only for coronary heart disease but also for overweight and obesity.”24

So here we have a hypothesis and some research on a high-risk population. And for people who were eating primarily meat, dairy and sugar, a diet that focused on whole grains and produce might actually bring about some positive changes. However, instead of doing further research to understand if this is actually a correct thing for every single man, woman and child, health authorities latched on to it and ran with it as if it was fact, promoting it for all. Doctors who were skeptical of the idea that the low fat diet was correct for every person accept infants were roundly criticized.

Harvard Medical School sums up the low fat diet this way: “Once the main strategy for losing weight, low-fat diets were shoved aside by the low-carb frenzy. But healthy fats can actually promote weight loss, and some fats are good for the heart; eliminating them from the diet can cause problems. Since fat contains nine calories per gram while carbohydrates contain four, you could theoretically eat more without taking in more calories by cutting back on fatty foods and eating more that are full of carbohydrates, especially water-rich fruits and vegetables. Still, such a diet tends to be less filling and flavorful than other diets, which lessens its long-term appeal. And if the carbs you eat in place of fat are highly processed and rapidly digested, you may be sabotaging your weight-loss plan.” Again, serious problems with the low fat diet as a long-term, blanket strategy for weight loss and health.

Despite emerging research on the importance of moderate consumption of healthy fats, we can still see the vestiges of the low-fat diet “gospel” in government supported food programs. Children at schools drink low fat or non fat milk. Women and children on WIC can only use their WIC vouchers to purchase whole dairy products under special permission- such as if the woman or child is severely underweight.

And this isn’t the first time an idea has quickly morphed from hypothesis to full blown public health campaign. Take Shaken Baby Syndrome– a diagnosis founded largely on research performed on adult baboons and confessions from people under severe emotional duress. Shaking a baby is still abusive and can seriously injure a baby, but the actual diagnosis of Shaken Baby Syndrome as the only cause of subdural hematoma in an infant has come into question in court cases and rightly so. Interestingly enough, we have a great deal of material on not shaking babies, but very little about other abusive behavior towards infant and children. Shaking is specifically singled out in these campaigns.

Or if we really want a throwback, how about the idea that circumcision of male infants should be routine because it would prevent masturbation and a proposed host of accompanying ills? Robert Darby’s paper on the subject notes the “insularity” of the American medical profession in clinging to a belief in “congenital phimosis” long after it had been debunked in Europe. Indeed, despite a mountain of evidence to the contrary, medical texts continued to promote circumcision as a preventative for masturbation into the 1970’s. Whatever your thoughts on circumcision, the point is that the reasons for its widespread promotion during the twentieth century were not scientifically grounded (but rather derived largely from social and cultural ideas) and were presented as fact long after scientific evidence had proved otherwise.

The list can go on and on of “sacred cows” that are founded largely on a belief that something is to true to be untrue or that we simply don’t want to believe it to be true. The mortgage market could never fall apart, it’s simply too safe. The NFL has a history of presenting flawed research as its proof that football players can not develop serious brain injuries from repeated head trauma. Enron was simply too safe and conservative an investment to fail. Madoff was too trustworthy to screw over the investment world.

Sure, you can go around waving research and credentials in people’s faces saying that it’s proof of what you want to hear. But that doesn’t mean the research was carried out in a systematic and unbiased manner or that its results are being correctly interpreted. Just think about next time someone tells you that the research on the safety and efficacy of vaccines is undeniable.

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I’m With Stupid

One of the interesting thing about discussing vaccination with pro-vaccine people is that they often think they more intelligent than a non-vaccinating person simply because they have taken the “right” stance. I can not count the number of college educated people who have said that they are grateful no one dies of mumps or rubella any more because of vaccination, who have no idea what an adjuvant is,  do not know that the smallpox vaccine has caused the most recent cases of diagnosed smallpox, do not know that pertussis in vaccinated individuals is frequently asymptomatic, and have no clue that most countries that declare measles “eradicated” have not actually met the requirements for doing so.

These good people are shocked when they find out that they don’t know as much as much as they thought. They were honestly under the impression that  a few “ra-ra- go team!” stories about Jonas Salk, Edward Jenner and the eradication of smallpox with some slogans from billboards and pediatricians and few buzzwords like herd immunity were all they ever needed to understand vaccination.

I have encountered doctors who tell patients that vaccine failure is impossible despite reports from health agencies which confirm otherwise. Others say that vaccine reactions don’t actually happen (despite the fact that our nation’s public health agencies have set up both a vaccine adverse reaction registry and compensation fund for vaccine adverse events victims). Of course it goes the other way too. I’ve seen a few people who spout vaccination conspiracy theories as their proof for their stance. And whenever either side runs out of ammunition they bring up dying children to bolster their view.

It’s human nature. It’s easier to join with the “right” side and not have to actually become educated- it saves us from having to actually ask uncomfortable questions that may cause us to question our current health practices. Of course, there is a lesson in all this. It’s never enough to be on the “right” side. Once you outsource your decision making process to other people, you put yourself in a position where you are relying on them to be 110% interested in your well-being with no self-interest. And that’s never going to happen. It’s far better to do the uncomfortable work to educate yourself. Don’t be with “stupid” and don’t be with “smart”. Inform yourself.

Tribeca

“It must be very fragile, if a handful of berries can bring it down.”- Katniss, Suzanne Collins’ Catching Fire

At first, I was pretty irritated that the Tribeca Film Festival was canceling their screening of Andrew Wakefield’s documentary about autism and the MMR vaccine. What about free speech?! Isn’t this censorship?! Then my husband reminded me that by pulling this film, there will probably be more attention than there would have been otherwise. Robert De Niro wouldn’t be sharing his own very personal story if this hadn’t happened. Banning things has a history of piquing peoples’ interest.

Conspiracy Theories and Vaccination

A little while back, I had the chance to go to the San Diego Zoo with my family. Over at the polar bears’ habitat, there was a big exhibit on global warming and how it affects polar bears. I mused over this for a little while. Climate change (formerly known as “global warming”) is still fairly controversial. People who don’t believe climate change is occurring are lumped in with moon landing hoax proponents and those irrational, deluded souls who don’t vaccinate themselves or their children. But here is the reality, if you start talking about climate change hurting the polar bears, you’re bound to start losing some people and could be written off as an extreme tree-hugging environmentalist. (Don’t you just love the way we all label each other?) A better tactic might have been something like this:

People come to see the polar bears. Polar bears are cute and fun. They’re fascinating and majestic. If people come and get to see the polar bears they will probably fall in love with them. Fill the exhibit with cool facts and pictures of polar bears in the wild- including cubs and mothers. (The San Diego Zoo is doing well up to this point.) Then start talking about the threats to polar bears survival, specifically habitat destruction- but don’t mention climate change. I know it seems counter-intuitive, but don’t mention climate change because if you do, people will dismiss threats to polar bears as paranoia. Tell people to reduce pollution, recycle, use eco-friendly products, etc. But don’t actually mention climate change. Because here’s the thing, whether climate change/global warming is occurring or not, whether it will cause polar bears to go extinct, whether human made pollution is responsible for some/all of the warming and what the ultimate outcome of it will be, reducing pollution, recycling and buying eco-friendly products will be beneficial- and most people will agree to that.

Also, these strategies will beneficial to humans as well. (This is a problem that the public health community is facing- the separation of environmental health and public health is actually making it harder to gain support for environmental health policies, even if the policies would benefit people too. Helping people understand that helping the environment actually means helping themselves will be crucial to the advancement of public health.)

I think the same is true with vaccines and theories about possible ulterior motives to vaccination programs. Personally, I think the greatest threat to vaccine choice is probably not pharmaceutical companies and the AMA, but rather people who use conspiracy theories instead of data to back up their stance opposing vaccines. Now part of the reason I think this happens is that people hear that the science behind vaccines is completely settled and there is nothing more to debate about it. So they feel they need to poke holes in vaccination through other means- instead of questioning whether or not the data on vaccines is airtight.

But here’s the thing about conspiracy theories: they’re not relevant to the actual question of whether or not vaccination is effective- and that is the real issue. Yes, it is entirely possible that eugenics was related to the vaccine campaigns of the late 1800’s and early 1900’s. Eugenics was considered a fact at the time. (However, it’s also possible that in the Industrial Revolution the medical community was simply enamored with idea of the latest technology eliminating disease and ushering us into a brave, new world of amazing health with a huge profit potential.) Could vaccines be related to population control strategies? Maybe. Perhaps, you believe that the moon landing was a hoax, that the Holocaust never happened, that the JFK assassination and September 11 (either one or both) were inside jobs. You are entitled to your beliefs (though I will disagree with you on all counts). But none of those things actually have anything to do with whether or not vaccines are effective and trying to bolster your stance by adding what might be viewed as “conspiracy theories” are only going to hurt you and everyone else. It wouldn’t matter if all of the above were true, because if they were but vaccines were really 99.9% safe and effective, people would choose vaccination. And that is the real problem- people think vaccines are 99.9% safe and effective when they actually aren’t. Thus, it’s important to deal with vaccines on the effectiveness level.

And as for the polar bears, looking at the problem from another perspective outside of global warming/climate change could be very beneficial. Running a scenario where we look for other possibilities outside of climate change could help us see new solutions or new threats to the polar bears that might otherwise be overlooked. From a scientific perspective, I think it pays to be thorough. (For an interesting article on polar bears and the climate change controversy take a look at this article from the BBC.)

Information for Parents About Vaccines- A Study of the Dissemination of Ignorance

“I do not approve of anything that tampers with natural ignorance. Ignorance is like a very delicate exotic fruit. Touch it and the bloom is gone.”– Lady Bracknell, The Importance of Being Earnest, by Oscar Wilde

“I trust doctors, not know-it-alls.”- Kristen Bell

“Just because a baby dropped out of you doesn’t mean a PhD did.”- Pro-vaccination Facebook meme

Trusting doctors and scientists is the smart thing to do isn’t it? After all, they have had years, even decades of schooling and the information they learn in medical schools and PhD programs is absolutely proven- otherwise it wouldn’t be a part of the curriculum.

But what if it’s not?

What if the curriculum taught in universities and medical schools about medicine and disease prevention is influenced by politics, economics, and cultural biases?

Oh, that is a very scary place, isn’t it?

It means that the information we get from health officials and doctors may not be completely accurate. (Gasp! We might gain greater scientific knowledge in the future and find out some of our current medical practices are based on faulty assumptions- like bleeding patients and prenatal x-rays were. You mean we don’t everything right now?!)  It means that profit motive could play a role in how medical treatment and procedures are administered and represented to us. It’s so scary that we would rather turn a blind eye and not examine that possibility and continue living in ignorance. And that brings us to agnotology- the study of willful acts to spread confusion or deceit.

Agnotology is a relatively new field of academic study and has yielded a great deal of interesting information about how businesses and even governments have used the deliberate spread of misinformation to keep people from understanding the truth about something. Quoting a LA Times article (where columnist Michael Hiltzik displays his own ignorance by claiming that people who oppose vaccination base their entire position on one discredited study): “The tobacco industry was a pioneer at this. Its goal was to erode public acceptance of the scientifically proven links between smoking and disease: In the words of an internal 1969 memo legal opponents extracted from Brown & Williamson’s files, “Doubt is our product.” Big Tobacco’s method should not be to debunk the evidence, the memo’s author wrote, but to establish a “controversy.” From a BBC article on the tobacco company’s efforts to create confusion: “[Science historian Dr. Robert Proctor of Stanford University] had found that the cigarette industry did not want consumers to know the harms of its product, and it spent billions obscuring the facts of the health effects of smoking.” Remember, folks, there was a time when smoking was considered very safe- even by doctors- and a big part of that was deliberate efforts of the tobacco companies to discredit research that showed their products caused cancer.

How about another example of agnotology and medical science? From the late 1800’s to about the middle of the twentieth century so-called “racial hygiene” was considered a public health necessity. It did not originate from the Nazi’s in World War II, it was already being preached and practiced as the best way to maintain a healthy populace in both Europe and America. In fact, America was among the first countries to institute sterilization laws for those considered unfit to reproduce. That was in 1907. It would be a decade more before Germany began instituting such laws. Racial hygiene was taught as a fact in medical and nursing schools in Germany and other countries. It was held up by research from MD’s and PhD’s claiming that people of other races were intellectually inferior. Sterilization laws soon gave way to “mercy killings” of the mentally ill or disabled and soon to mass genocide of Jews, gypsies, homosexuals and other groups deemed to be a burden on public health. (I highly recommend reading all of the aforementioned link. It’s a summary of Dr. Proctor’s very comprehensive look at the how the Nazis influenced the medical system of Germany.)

So for all of you who loudly proclaim that you trust your doctors and do what they tell you because doctors and PhD’s know best, how about this? What would you do if your doctor told you it was a public health necessity to execute your neighbor because of her ethnicity? Or how about a special needs child? What about someone who was disabled or suffered depression? Would you be the type of person who steps back and says, “Now wait a minute. These people may not be like an artificial ‘ideal’, but their lives have value- many of them can have a very positive impact on our society if we let them. Even if the experts are saying one thing, they could be wrong.” Or would you be turning in your neighbor or handing your disabled family members over for a mercy killing because it is the “scientific” thing to do? If you have ever said that you vaccinate yourself and your child because you trust doctors and scientists, think very carefully about your answer. (Kristen Bell, care to field this one?)

Let’s take a look at vaccine information now. For those of you out there who are vaccine proponents and claim to believe in facts, logic and research, you should have absolutely no problem with comparisons of vaccine information distributed to parents with epidemiological research on the diseases and medical facts about the vaccines.

Let’s start with Hepatitis B.

The CDC’s information page for parents on Hepatitis B claims that “of the more than 1 million people in the United States living with lifelong Hepatitis B, most got the virus as a child” and that “When infants and young children are infected with Hepatitis B, they have 90% chance of developing a life-long, chronic infection”. The CDC says that Hepatitis B can be passed through more every day means such as chewing food to give to a baby, sharing toothbrushes and gum and touching open cuts or sores. Statements like these may give the impression that Hepatitis B is a disease that frequently affects children and that transmission outside of sexual contact, needle sharing and maternal transmission are also frequent phenomena.

However, reports of epidemiology presented at the National Institutes of Health Workshop on the Management of Hepatitis B show a different breakdown. Their statistics show that 45% of all new HBV infections in the United States are sexually transmitted, with injection drug use causing another 21% of cases and the remainder (33%) being cases of mother-to-child transmission occurring at birth or in the first few years of life. (pg. 20) Overall, the CDC statistics show that rate of HBV infection is very low in the United States and Canada, averaging 0.1 to 0.5% for current or chronic infection, however the rate of infection is much higher among native populations and Asian emigres. About 5% of Americans have been infected with the hepatitis B, but 90-95% of the time these cases are cleared by the immune system on its own, especially in adults. (See page 19 under the heading “Canada and the United States”.) Child-to-child transmission of hepatitis B (mostly through contact with open sores) has been well documented in developing countries. In the United States and other developed countries child-to-child transmission incidents have been extraordinarily rare, even in daycare and school. Urine and feces are not vehicles for transmission unless blood is present and oral transmission of hepatitis B is almost non-existent. (pg. 48 under heading “Risk of Hepatitis B Infection in Daycare Centers”.)

So notice that while CDC’s information for parents has some truth in it (that HBV can be spread through sharing personal care items and that children have a greater chance of developing a lifelong HBV infection than adults). However, there are a couple of big, glaring factual omissions here. One is that the overall rate of HBV infection in the United States is very low. This is not a common disease, so the chances of an individual in a low-risk population contracting are extremely low. The other omission is that almost all children who are infected with HBV contract the virus through mother-to-child transmission either at birth or in the first few years of life, so unless the mother is infected at birth or during the child’s first few years of life, the chances of a child contracting HBV are extremely low. The other thing they fail to mention is that incidences of child-to-child transmission of HBV are extraordinarily rare in the United States and other developed countries. This vaccination is becoming required by more and more states for entrance into kindergarten, but ironically enough parents and doctors can vaccinate all the kindergarteners they want, but the small number of children who are most at-risk for HBV infection will probably contract the infection at birth or before they enter kindergarten from their mothers. In other words, vaccinating kindergarteners for HBV is one of those feel-good measures that doesn’t actually accomplish much. The CDC’s information for parents on HBV is deliberately misleading.

Moving on, let’s take a look at pertussis next. The CDC says this about pertussis prevention:

“Pertussis (whooping cough) can lead to serious illness, needing treatment in the hospital, and death — especially in babies who are too young to be well-protected by vaccines. You can help protect your baby from pertussis by:

  • Getting a pertussis vaccine (Tdap) if you are pregnant
  • Encouraging those around your baby be up-to-date with pertussis vaccination
  • Making sure your baby gets his pertussis vaccines on time”

But here is what they are not telling you about pertussis and pertussis vaccination:

I could go on and on with other diseases, but you get the idea. So let’s review here: the information that is distributed to parents from agencies like the Centers for Disease Control leaves out several very important facts and twist others to present an unrealistic picture of the risk for diseases and the benefits of vaccines. The doctors, scientists and public health professionals at the CDC are considered very educated about the spread of disease, so unless the people employed there are in reality extremely ignorant about diseases and their spread (and therefore unqualified for their positions), we can only assume that they are deliberately keeping parents from this information. Sounds like a subject worthy of agnotology.

A Realistic Picture of Cancer Vaccines

What if a local car dealership was advertising the most amazing sale? Something like “Get a BMW for nothing down and as little as $199 a month!” Would you just walk into the dealership, pick out a BMW and sign a contract without looking at the actual terms of the sale? I’m guessing you just scoffed and said “Of course not! That sounds too good to be true there must be a catch. Of course I would want to find out exactly what I am signing!”

But why? After all, isn’t the car salesman an expert at selling cars? Doesn’t he know more about car sales than you? If he’s the expert, why do you need to do any further research?

Well obviously because there can be all kinds of limitations to a deal like this. Maybe the BMW is used, maybe it depends on having a stellar credit score, maybe $199 only applies to the cheapest model on the lot, and on and on. Obviously, the salesman has a vested interest in you saying “yes” to the deal. His livelihood depends on people buying cars from him.

OK, so what if your doctor tells you that you can prevent or fight cancer with a simple vaccine injection. It saves lives, it’s simple, it’s extremely safe and extremely effective. Do you bother reading “the fine print”? Do you read the product insert? Do you objectively evaluate the information, looking not just for the benefits, but also the limitations? Chances are, if you are like most Americans you will probably spend more time reading the fine print on a car sales contract than researching what cancer vaccines (or many other medical procedures) realistically can and can not do for you or your loved ones.

We’re accustomed to thinking of any new technological advancement in medicine as effective and positive- regardless of actual results. And it’s hard not to when you hear the enthusiasm of doctors and the media about the latest high-tech treatment to debut. It’s exciting, it’s promising, it’s hugely beneficial, it’s the future and it will make everyone’s lives better. It’s hard not to want to be a part of that sort of excitement! Especially when it means taking some kind of action against a condition that may make you feel otherwise powerless to do anything about. Even if the results aren’t actually very effective, just doing something- anythingcan take away some of those feelings of powerlessness.

Let’s start with a few basic problems for cancer vaccines in general. First, is that the concept of vaccination is built on the idea that the immune system will attack foreign bodies like bacteria and viruses and that vaccines can introduce weakened versions of these infectious agents and stimulate the production of antibodies that bind to specific, targeted microbes and block their ability to cause infection. And of course, this is based on the idea that we can get the immune system to “remember” all kinds of diseases for a long term immune response- similar to natural immunity acquired from measles, chickenpox, smallpox etc.

Now, the first problem with the idea of a cancer vaccine is that cancer does not work like viruses such as measles, chickenpox and smallpox. (This rarely occurs to people when they think about vaccination.) If you become infected with any of the aforementioned diseases, you gain lifelong immunity if you fully recover- which most otherwise healthy people will. We know that if you develop cancer, you can get it again. Cancer does not imprint on the immune system the same way infectious diseases do.

So aside from the fact that many vaccines for infectious diseases can be very ineffective, we are talking about applying a solution that has been developed for infectious diseases and applying it to a non-infectious disease to which you can not develop natural immunity and assuming that it will work because it is claimed to have worked with infectious diseases to which you can develop lifelong immunity. And while I think some researchers may have an understanding of this, most laypeople don’t seem to understand this basic concept. (And neither the researchers nor the news media certainly haven’t wanted to bring it up either.)

In fact, from the summary of research on a preventative cancer vaccine heading into human trials, comes another problem with cancer vaccines in general. The tumor antigens are variations of self proteins that the body makes and would probably cause profound autoimmune complications if used in a preventive vaccine. Nonetheless, the researchers feel that their research on mice has proven highly successful. The news media and proponents have been loudly optimistic. Yahoo! News quotes a breast cancer surgeon who claims that it is “100% effective in animal models”. (In contrast, the MMR II package insert states that “As for any vaccine, vaccination with M-M-R II may not result in protection in 100% of vaccinees.”) Human trials began late last year. We will have to see what further research shows.

Optimism and enthusiasm can be contagious- but also misleading or even dangerous. A new vaccine designed to treat breast cancer that is in human trials has been deemed completely safe- after being tested on fourteen women.  Now, if you start thinking statistically, you will notice a glaring problem here. There are many side effects that have a 1 in 25, 1 in 50, 1 in 100 or 1 in 1,000 chance of occurring. Take, for example, the MMR II vaccine. If you read through the package insert, you will find that the chances of a life-threatening anaphylactic reaction to the vaccine are about 1 in 1,000. The chances of this kind of side effect showing up in a trial of just fourteen people are extremely small. Curiously, the co-author of the study on the breast cancer treatment vaccine has been quoted as saying that he doesn’t “want to oversell this” while going on to say that despite the vaccine’s very small trial “…we can say confidently that the vaccine was safe”. I’d be interested to see what he would call “overselling”…

At this point there are only two preventative cancer vaccine approved in the United States: Cervarix and Gardasil for prevention of human papillomavirus infection and subsequent cancer. One cancer treatment vaccine has been approved, Provenge, for use in men with metastatic prostate cancer. However, Provenge is not a “silver bullet” against prostate cancer. It is approved only for certain types of cancer and what it actually does is increase survival of these patients by four months.

We’re not talking about a cure here, we’re talking about prolonging a dying person’s life by a few months. The decision about whether to prolong a dying person’s life by a few months is a highly personal one in my opinion and isn’t really the issue here. The point here is understanding what exactly it means to treat cancer with a vaccine and the results that can be expected. And Provenge is a reminder of the caution we need to take with the enthusiasm about breast cancer treatment vaccines. So far the results that have been released for the 14 person mammaglobin A trial claim that the vaccine has halted cancer progression in 50% of the patients in that trial (about 7 people) for a year. How this vaccine will work on more than fourteen people or for longer than a year isn’t known.  Considering that half of the patients in this trial still had cancer progression at a year, the result for many women may still be something similar to Provenge where patients with certain types of breast cancer may be able to survive for a few months longer than they would (on average) with other treatments.

And yet another problem with both cancer vaccines and vaccines in general lies in the issue of adjuvants. Immunologists know that the killed and live bacteria and viruses in vaccines are often not enough to elicit a reaction from the immune system. (For a more detailed discussion of adjuvants, see my post here.) The National Cancer Institute  states: “Antigens and other substances are often not strong enough inducers of the immune response to make effective cancer treatment vaccines. Researchers often add extra ingredients, known as adjuvants, to treatment vaccines. These substances serve to boost immune responses that have been set in motion by exposure to antigens or other means.” So again, though the adjuvants are supposed to help “boost immune response”, your immune system is often not reacting to the actual antigens in the vaccine, but rather to the adjuvants. The big question no one really asks is whether the immune system is actually being “trained” to recognize and fight diseases when it’s responding weakly (if at all) to the disease antigens in a vaccine.

 

What Does It Mean When A Disease Is Declared Eliminated/Eradicated?

“This announcement might be premature in view of the unreliability of statistics in underdeveloped countries.”Noted medical historian Erwin H. Ackerknecht on the announcement of the eradication of smallpox (See page 507 of cited document.)

We’ve heard the claim before: “Vaccines have eradicated smallpox from the whole world and diseases like polio and measles from many developed nations.” But do you know what eradication or elimination of a disease really entails?

Most people think that when a disease is declared eliminated or eradicated that the virus or bacteria has become extinct in that area or the entire world- like the dodo bird or quagga. What it usually means is simply that the disease has been declared eradicated or eliminated. Allow me to explain in further detail…

The concept of disease elimination is rooted in the theory of community (herd) immunity- that a disease won’t be able to take hold in a population with high immunity- especially highly vaccinated populations. This sounds like a great idea “on paper”, but real world applications pose numerous problems. Efficacy is often far less than health organizations would like to admit. I’ve listed these well-documented cases from medical and scientific literature before, so if you would like to see them, read this post here for a good collection of cases of vaccine failure. Generally, the assumption that is made with elimination of a disease is that almost all individuals who have received the vaccine are immune to the disease and that immunity will last for very long periods of time. However, the reality of vaccine efficacy is much different.

A great example is the flu vaccine. The CDC has released a statement saying that the 2014 flu vaccine was only about 14% effective. They say it is usually more like 50-60% effective. Since herd immunity generally requires anywhere from 75-95% of a population to be immune, there is simply no way herd immunity could ever be achieved through the current influenza vaccination. Even if 100% of  eligible population were to be vaccinated, the maximum immunity would only be about 60%.

Yet another example is pertussis. A survey of nine counties in California showed that between 44 and 83 percent of individuals with pertussis had been immunized. Again, at those rates of failure even a fully vaccinated population will not result in herd immunity- especially when the threshold for community immunity for pertussis has been set at 92-95%.

And yet another example lies in measles. The Huffington Post reported on this here. Renowned vaccinologist Dr. Gregory Poland states that the MMR shot is not effective at preventing measles. He says that it is both far less effective than anticipated and that immunity from it quickly wanes. Despite all this, he also condemns in no uncertain terms those who refuse vaccination. (So you’ve told me that your solution doesn’t work, but I must still get it or I will be hurting others by not getting the ineffective solution? And yet I am dismissed as the emotional, unscientific one?) In a situation where immunity is conferred but quickly wanes, even if you had that “community-immunity-dream-come-true” where 100% of the eligible population has been vaccinated, because immunity is very brief, widespread immunity will be achieved only for short periods of time if at all.

(Penn and Teller, would you care to do a video where you explain how the above examples factor into community immunity?)

Moving on to the next issue with elimination and eradication, let’s talk about vaccines spreading disease. Yes, I can see the eye rolls now. Most dismiss this as fear mongering from people who where foil hats on their heads to prevent the government or the Illuminati or aliens from reading their minds. However, it is actually medically documented and is one of the prime reasons that we no longer vaccinate for smallpox. Page 501 of an article in the 1983 Microbiolocial Review details several cases of individuals who were vaccinated for smallpox after the disease was declared eradicated and subsequently became reservoirs for the vaccinia virus and passed it to others. Many of these cases came from military personnel who were vaccinated for smallpox and then passed the virus to other military personnel or family members such as children who then passed it to others.

And herein lies yet another problem with campaigns for eradication of a disease. The chances of any one person becoming a reservoir for pathogen is probably relatively small. But when you start having mass vaccination campaigns where many vaccines are being administered, the chances increase that someone is going to become a reservoir and start passing the disease. If there is a relatively high failure rate of the vaccine, the potential exists for several individuals to become infected even in a highly vaccinated population. This probably explains why during the smallpox eradication campaign areas that had very high levels of vaccination were still seeing cases of smallpox. (See page 491.)

But even with all these problems with eradication, smallpox was still declared eradicated. How did they do it? Well let’s take a look at the criteria for declaring smallpox eradicated. Going back to the 1983 Microbiological Review, the criteria for declaring eradication of smallpox required that no cases of smallpox had been reported within the last two years and that the country’s epidemiological surveillance system be evaluated and declared adequate by the World Health Organization (pg. 498).

Now surveillance and reporting bring up a number of interesting problems. The United States has a great surveillance system for diseases and yet not every disease is reported. (I never let the authorities know when my kids had chickenpox. There’s absolutely no incentive for me to do so since I would be met with persecution.) I know of other people who have “flown under the wire” with pertussis, chickenpox, the flu and even measles.

We have also seen that even in countries whose reporting and surveillance systems are adequate that breakdowns- or abuses can occur. Initially, rewards were offered for reporting cases of smallpox, but there came a point when a country’s health authorities didn’t want to report smallpox cases because it would interfere with gaining eradication status. Health officials in Somalia suppressed information about smallpox cases in the final months of that eradication campaign, not wanting their country to bear the stigma of being the last to harbor the virus. In a more recent occurrence, China kept information about its SARS outbreak secret.

The other problem with surveillance is that especially in vaccinated populations, diseases can frequently be asymptomatic. Modified measles is a medically documented phenomenon in which individuals who have been vaccinated for measles still contract the virus but because of the vaccine don’t display the typical the symptoms of the disease. The characteristic spots associated with measles are very frequently absent in modified measles. Most doctors aren’t very familiar with this so they won’t consider it a possibility in vaccinated individuals or test for it. A similar phenomenon called atypical measles was noted when the killed strain measles vaccine was in use. Pertussis is notorious for this. It is a medically documented fact that individuals who have been vaccinated for pertussis and contract the disease often don’t display any symptoms.

Furthermore, declaring measles eliminated is in many ways like a “self-graded” test. The WHO Regional Office for the Western Pacific (WPRO) has a set of criteria for the definition of elimination of  measles. However, their definitions have changed over the years. Originally the definition for measles elimination required zero incidence of infection within a defined geographic area. Now, measles elimination is defined as “the absence of endemic measles transmission and the lack of sustained transmission following an importation of measles virus in a large and well populated geographical area.”

Now here is where things get interesting. A report from the World Health Organization on the elimination of measles in Australia states: “Australia, like many other countries that have declared elimination, would have difficulty meeting the WPRO elimination criteria based on currently available reporting of the investigation of presumptive measles cases (Table 2, available at: http://www.who.int/bulletin/volumes/87/1/07-046375/en/index.html). However we believe multiple lines of evidence conclusively demonstrate the elimination of endemic measles transmission from Australia since 2005 at the latest.” OK, so Australia and most other countries that have declared measles eliminated haven’t actually met the WPRO’s definition of elimination, but these countries feel they have done a good job, so they can declare measles eliminated? This is the scientific basis for the elimination of measles? In fact, there is a nice little chart on the WHO’s site showing all the ways that countries that have declared elimination of measles have met and not met the WPRO’s definition for measles elimination. If you take a look at this chart, it shows that Australia has neither a low incidence of measles nor a high quality surveillance system, however, they can still declare measles eliminated within their borders.

And on top of all this are disease associated side effects with vaccination. Provocative polio is a well-documented example of this. In 1998, Drs. Matthias Gromeier and  Eckard Wimmer found that injury to tissue to during certain types of injections allowed the polio virus easy access to nerve channels, thereby increasing the likelihood of paralysis. The more recent HV Wyatt study from 2003 found that three-quarters of children with paralytic polio receive injections just before the onset of paralysis. Then there is Vaccine Acquired Paralytic Polio. According to the CDC, between 1980 and 1999 162 cases of paralytic polio were confirmed in the United States,  154 of which were VAPP.

The other major assumption with the WHO’s eradication criteria is that if no new cases are reported after two years that the disease must be gone. A similar assumption has been made with polio eradication, and yet has proved faulty.  For example, in 2004 a case of wild type 3 poliovirus in Sudan was discovered when the last case in Sudan was detected in 1999. The criterion for certification of eradication is the failure to discover wild poliovirus for at least three years in countries with certification-quality surveillance- very similar to that of smallpox eradication. Genetic sequencing of the wild virus found in 2004 showed that it may have been circulating undetected in Sudan for more than three years—a time when surveillance in Sudan was thought to be satisfactory. Barrett points out that while surveillance probably was satisfactory at the national level, it must also be of an acceptable standard within every local district. As Sudan has been a high conflict zone, it is very possible that local surveillance may not have been adequate.

And to be realistic, during the smallpox eradication effort there were a number of countries embroiled in conflicts, such as the Vietnam War, the Cambodian civi war and subsequent “Killing Fields”, and the Soviet invasion of Afghanistan. Even the practice of apartheid in South Africa, for example, could have led to inequalities in surveillance and reporting. Not to mention the number of localized areas that were poverty stricken or remote that could lead to inadequate surveillance and reporting on a local or regional level.

Furthermore, another big weakness with the system is that once eradication status was granted to a country, surveillance for smallpox was not quite as careful. In fact, in 1987 it was recommended that smallpox be removed from the National Notifiable Diseases Surveillance System. However, surveillance began again after the September 11 attacks in 2001 because of the possibility of a bioterrorism attacks.

When assessed from a realistic perspective, the WHO’s criteria for eradication is based on the assumption that all components of a country’s reporting and surveillance for diseases are working perfectly- not well or adequately- but perfectly. That’s a pretty big assumption. (It brings to mind something I heard in a podcast interview with General Stanley McChrystal where Gen. McChrystal talked about the importance of a “red team” to do an outside assessment of a plan. He said that something can sound like the most brilliant plan when it’s your own head, but when you get other people to look at it, they can bring out the weak points and pretty soon you see that you aren’t dealing with a strategy, but rather a set of miracles based on everything working perfectly.)

But even with all of these very significant challenges in disease eradication/elimination, let’s for the moment assume that a disease in particular can or has been eliminated. When we talk about eliminating/eradicating a disease, it is because we believe it has very detrimental effects and that if eliminated/eradicated, that people will no longer suffer those effects. But are we really free from the detrimental effects of a disease just because it has been declared eliminated or eradicated? Let’s take a look at the data…

Smallpox: We’ve already established that cases of smallpox have been documented to spread from vaccinated individuals. However, even if smallpox is no longer a threat to humans, there are a number of other animal pox viruses that can cause similar symptoms and even death. Monkeypox is one of the more well studied examples of this as detailed in pages 503-506 of the Microbiological Review. However, there are a variety of other possible pox viruses that could take hold in humans including cowpox, camel pox, tanapox, rat pox, gerbil pox and raccoon pox.

Polio: Because of polio, no one has to worry about their child coming home sick and being paralyzed, right? Wrong. One interesting newspaper article from India asserts that while polio has been eliminated in India, Acute Flaccid Paralysis (AFP) is on the rise.  According to the Johns Hopkins School of Medicine, AFP encompasses all cases of poliomyelitis. And guess what? AFP can get you here in the United States too. Several cases of paralysis from non-polio enteroviruses have been reported in the United States.

Measles: Sure, it is possible to get encephalitis from measles. But guess what else can cause encephalitis? According to the Mayo Clinic, encephalitis can occur as a result of vaccination with a live virus vaccine– like MMR.

I think at this point we should be asking ourselves if it is really realistic or prudent to eliminate a disease causing pathogen. We talk a lot about the importance of the ecosystem and that if a species like a plant or insect goes extinct, it could upset the entire ecological balance of an area. Yet, our scientists feel that these laws do not apply to bacteria and viruses. Instead of trying to eliminate viruses and bacteria, perhaps it would be more practical and lifesaving to focus on efforts to help people avoid them through clean water and fight them off through better nutrition and healthcare.