Andrew Wakefield sues BMJ for claiming MMR study was fraudulent

Andrew Wakefield sues BMJ for claiming MMR study was fraudulent | Society | guardian.co.uk.

Poor Andy.  He writes a fraudulent article in The Lancet, which the prestigious journal eventually has to withdraw and his co-authors disown the same article.  Brian Deer, a journalist for the Sunday Times of London, uncovers the fraud and publishes it in the British Medical Journal.  Andy tries to sue Deer in UK courts, but essentially loses and has to pay all court costs and legal fees.  Eventually, Andy is stripped of his medical license in the UK.

So, I guess the only choice of a fraud is to sue those who told the truth.  Yes, this would be an ironic, even funny story, except for the deaths of children who should have been vaccinated against preventable diseases but weren’t because the parents heard about Andrew Wakefield’s fraudulent story.

 

A year without polio in India

A year without polio in India > Media room > Global Polio Eradication Initiative.

In two years, India went from the country with the most cases of polio to one with zero cases.  They didn’t do this with magic water or pseudoscience, but good old fashioned vaccines.

We can be polio free

Another bogus anti-vaccination paper

I use Twitter not only to tweet about my favorite sports teams, but to see what’s being said in science, medicine, politics, and anything interesting. I actually have a list (you can read by list if you want) that I call “Pseudoscience” that are tweets from the biggest anti-science medical people around. Today, I received the following tweet:

So that lead me to a post at “Natural News” (OK, I’ll admit that my skeptical radar fired up) entitled, “Medical journal openly questions science, ethics of HPV vaccinations.” As an aside, Natural News’ url for the article is “vaccinations_quack_science_medical_journals.html”; not very subtle are they?

First a little background is necessary before starting this story. Gardasil (Merck’s brand name) is a vaccine against human papillomavirus (HPV), a sexually transmitted virus. In early stages, HPV only results in mild symptoms like warts in the genital and anal areas, but in some cases can lead to cervical cancers. The vaccine not only prevents the transmission of the disease but seems to reduce the long-term risks of cancer.

But, I digress.  Imagine my reaction to the article.  “Oh no, HPV vaccinations are unethical!!!!!” Call the police. I’ve been all wrong about vaccines. Oh wait, let me look up the original article, because even very unbiased news sources like the Wall Street Journal and New York Times sometimes get medicine wrong. Let me run over to the article before I post my mea culpa about vaccines.

The article, Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?, published in the Annals of Medicine in December 2011. The authors, Tomljenovic and Shaw are associated with the University of British Columbia, Department of Ophthalmology. I don’t want to degenerate into some sort strawman fallacy, but I question why two individuals in a medical specialty, ostensibly involved with the eyes, are so obsessed with vaccines. Furthermore, they have a long history of anti-vaccination papers, most published in low impact journals. For example, they recently published an article correlating aluminum with autism, though the correlation is specious and providing no causality. One of the worst mistakes of research is conflating causality and correlation.

Moving on to the article, their abstract states:

All drugs are associated with some risks of adverse reactions. Because vaccines represent a special category of drugs, generally given to healthy individuals, uncertain benefits mean that only a small level of risk for adverse reactions is acceptable. Furthermore, medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to women indicates that such disclosure is not always given from the basis of the best available knowledge. For example, while the world’s leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination. Future vaccination policies should adhere more rigorously to evidence-based medicine and ethical guidelines for informed consent.

I won’t go through each point, but a couple are important to refute:

  1. Uncertain benefits.  The Centers for Disease Control disagrees.
  2. Clinical trials show no evidence that HPV vaccination can protect against cervical cancer.  This is partially true, since HPV-related cancers can take from 15-25 years to arise.  Epidemiological data takes time.  However, we know that HPV is the cause for several types of cervical and other cancers, so preventing HPV is a logical choice to make, given the prevalence of the virus.
  3. Vaccination polices should adhere more rigorously to evidence-based medicine.  It does already.  Pretty strongly.  Anti-vaccination, as best as I can tell, is based on fraudulent journal articles (see anything by Andrew Wakefield).

HPV vaccine is safe and efficacious. If you need more information on the HPV vaccine safety, the good researchers at Science Based Medicine did a great article called, The HPV Vaccine (Gardasil) Safety Revisited.

Let me make this clear. Every single medical procedure, pharmaceutical, and device has some risk associated with it. Can you get an infection at the injection site? Yes! Can you be allergic to the injection? Yes! Can it cause paralysis? No. Can it cause a broken leg? No, though if you did a random study, you’d find a large percentage of young girls who broke their legs within six months of being vaccinated, so obviously correlation is equivalent to causation. Or it doesn’t.

If Tomljenovic and Shaw could prove either no benefit with some measurable risk, or little benefit with large risk, then there is an ethical issue with the HPV vaccine. But actually, there is a high level of benefit with almost no risk, or risk that actually is imaginary rather than shown in evidence based medicine. You see, just because you use “evidence-based” in your article title, it doesn’t mean you actually follow it.

HPV vaccine should be recommended for all young men and women (yes, I said men too), reducing the future risk of cancer and it’s burden to the family, individual and health-care system.

WHO | 10 facts on immunization

WHO | 10 facts on immunization.

  1. Immunization prevents an estimated 2.5 million deaths every year.  Immunization prevents deaths every year in all age groups from diphtheria, tetanus, pertussis (whooping cough), and measles. It is one of the most successful and cost-effective public health interventions.
  2. More children than ever are being reached with immunization.  In 2010, an estimated 109 million children under the age of one were vaccinated with three doses of diphtheria-tetanus-pertussis (DTP3) vaccine. These children are protected against infectious diseases that can have serious consequences like illness, disability or death.
  3. An estimated 19.3 million children under the age of one did not receive DTP3 vaccine.  Seventy percent of these children live in ten countries, and more than half of them live in WHO’s Africa and South-East Asia regions.
  4. Over 1 million infants and young children die every year from pneumococcal disease and rotavirus diarrhea.  A large number of these deaths can be prevented through vaccination.
  5. Public-private partnerships facilitate the development and introduction of vaccines.  For example, a new vaccine which prevents the primary cause of epidemic meningitis in sub-Saharan Africa, meningococcal A, MenAfriVac, was introduced in Burkina Faso, Mali and Niger last year. At the end of 2011. Cameroon, Chad and Nigeria are vaccinating more than 22 million individuals with the vaccine which has the potential to eliminate the leading cause of meningitis epidemics in Africa.
  6. The supply of influenza vaccines has been significantly expanded.  The expansion has been possible as a result of WHO supporting the efforts of vaccine manufacturers to produce and license influenza vaccines in 11 developing countries.
  7. Global measles mortality has declined by 78%.  Global measles mortality has been reduced from an estimated 733 000 deaths in 2000 to 164 000 deaths in 2008, thanks to intensified vaccination campaigns.
  8. Polio incidence has been reduced by 99%.  Since 1988, polio incidence has fallen by 99%, from more than 350 000 cases to 1410 cases in 2010. Only four countries remain endemic – Afghanistan, India, Nigeria and Pakistan – down from more than 125 countries in 1988.
  9. Annual deaths from neonatal tetanus have fallen.  Neonatal tetanus deaths have declined to an estimated 59 000, down from 790 000 deaths in 1988.
  10. Immunization provides an opportunity to deliver other life-saving measures.  Immunization not only protects children from vaccine-preventable diseases. It also serves as an opportunity to deliver other life-saving measures, such as vitamin A supplements to prevent malnutrition, insecticide-treated nets for protection against malaria and deworming medicine for intestinal worms. In addition, the benefits of immunization are increasingly being extended across the life course to include adolescents and adults, providing protection against life-threatening diseases such as influenza, meningitis, and cancers that occur in adulthood.

Has there been a more successful human medical effort in the history of man?  No.

Vaccines–once more with emphasis

As I’ve discussed previously, I find the anti-vaccine movement, linking cases of autism to pediatric vaccinations, to be based on pseudoscientific principles.  There are several individuals that have pushed this quackery, but one of the more visible is Jenny McCarthy, ex-Playboy Playmate of the Year (no, I’m not going to link to it), bad actress, and failed game-show host.  I am flabbergasted, befuddled, and generally gobsmacked that anyone would listen to this woman, a scientific illiterate, about anything outside of how to model and possibly how to choose a career in bad movies.  That parents are making decisions about vaccinating their children based on her bogus beliefs is beyond my simple understanding of the world.  I guess if you get an endorsement from Oprah Winfrey, you have power!

However, there are always consequences to every action, and there are many by delaying or refusing vaccinations.  The Jenny McCarthy Body Count is a website that lists every vaccine-preventable case and death that has occurred since Jenny made public her belief that vaccines caused autism in her son (which many believe is a misdiagnosis) in June 2007.  Since then, there have been 142, oops, I mean 866 preventable deaths (as of today).  (As an aside, I had taken a screenshot of the Body Count three years ago to make a presentation, and the number was 142.  It is horrifying that the number has increased 7X since then.) As the website says, she’s not responsible for everyone one of these cases or deaths.  But if she convinces just one person to not adhere to a vaccine schedule for their children, then it’s one too many.

This body count, and Jenny McCarthy’s involvement, would be funny in any other context.  Children contracting diseases that can be easily prevented, with few or any side effects, is irresponsible and abusive.  An 18 month old child cannot decide whether they receive a vaccination or not, so we must rely upon well-informed parents to make certain it happens.  The anti-vaccine movement, based on junk science, causes harm.

And remember, the counter for the number of children who have been diagnosed with autism that has been linked to vaccinations remains at 0.

Time to return to your movies Jenny.

Good job vaccine denialists

The anti-vaccinationsts have had a lot of success in Europe recently.  According to the European Centre for Disease Prevention and Control, they report these rather gloomy statistics for measles during the Jan-Oct, 2011 time period:

  • France–nearly 15,000 measles cases
  • Italy–over 4,500 cases
  • Spain–almost 1,900 cases
  • Europe–over 28,000 cases

Measles is a totally preventable disease with an extremely safe vaccination.  And even though there is a belief that measles is not that dangerous, acute measles has a 15% mortality rate.

I see these stories, and I wonder if the anti-vaccination zealots sleep at night knowing the harm they cause.

How pseudoscience makes its case. Part 3.

This is part of my ongoing discussion on how quacks use pseudoscience to push their myths and potions on the world.  Part 1 discussed the scientific method, which allows us to objectively analyze the natural world.  Part 2 discussed the best way for us to examine the difference between science and pseudoscience.

I just read an outstanding analysis, by Steven Novella, MD, a clinical neurologist at Yale University, of how pseudoscience (those who pretend to praise the scientific method, yet do it in a way that is not actually science) and anti-science (those who repudiate science outright, or even undermine science, with subjective analysis and untestable spirituality) to reject evidence-based medicine.

Dr. Novella clearly states how science in medicine works:

This leads us to the final continuum – the consensus of expert opinion based upon systematic reviews can either result in a solid and confident unanimous opinion, a reliable opinion with serious minority objections, a genuine controversy with no objective resolution, or simply the conclusion that we currently lack sufficient evidence and do not know the answer. It can also lead, of course, to a solid consensus of expert opinion combined with a fake controversy manufactured by a group driven by ideology or greed and not science. The tobacco industry’s campaign of doubt against the conclusion that smoking is a risk factor for lung cancer is one example. The anti-vaccine movement’s fear-mongering about vaccines and autism is another.

Basically, science evolves over time.  A conclusion that lacks sufficient evidence may eventually be supported by better analysis or groundbreaking research.  You’ll notice that anti-science and pseudoscience pushers do not allow themselves to participate in the this continuum of research–they state emphatically that they are right.

Science, by its very nature, must be falsifiable, meaning that any hypothesis or theory has the logical possibility that it can be contradicted by an observation or the outcome of a physical experiment. Just because a hypothesis or theory is “falsifiable,” we do not conclude that it is false.   To the contrary, we understand that if it is false, then some observation or experiment will provide a reproducible result that is in conflict with it.  Simply put, science assumes that it has it all wrong, and attempts to determine why a particular theory or hypothesis is wrong.  Of course, in these attempts, usually more evidence is found to support the original theory.  Just because science requires falsifiability, that does not mean that it will ever be falsified, but science is open to the possibility.  In other words, science evolves.

Pseudoscience, by its very nature, is not falsifiable.  It is mostly based on assertion rather than scientific observation, so it cannot be tested by experiment or observation.  Creationism is a perfect example.  It is based on a human text (the bible), so there is no experiment that could be designed to test the text, since it non-responsive in a natural sense.  It would be like trying to scientifically show that the muppets existed.

Two of the most misused and misunderstood terms in evaluating scientific evidence are correlation and causation, two powerful analytical tools that are critical to evidence based medicine.  Correlation is the grouping of variables that may occur together.  For example, smoking correlates with lung cancer in that those who smoke tend to develop lung cancer at a statistically significant rate.  It’s important to note that correlation does not prove causation.  However, once you have numerous well-designed studies that correlate lung cancer to smoking, along with adding in biological and physiological models that support the correlation, then we can arrive at a consensus that not only is smoking correlated with lung cancer, it causes it.

We observe correlations every day.  But they are subjective observations for which we cannot state a causal relationship without substantial research.  The anti-vaccination movement is rife with these observations which they use to “prove” a cause.  An anti-vaccine conspiracy website claims that pregnant women are miscarrying babies after getting the shot.  The fact is that there is a statistical chance that women will miscarry during any pregnancy.  This is random variability not a cause.  In fact, based on the rate of miscarriage, we could expect that thousands of women would miscarry within 24 hours of getting the H1N1 flu shot.  But it’s not correlation, unless significant studies show a causal relationship.  For example, I’m also sure that thousands of people broke a bone or had a desire to eat a burger after getting the shot, but that’s because in a large enough population of individuals, you can find literally millions of different actions after getting a shot.

So, the miscarriage rate after receiving the swine flu shot is not correlated.  It’s just a random observation.  And there is no biological cause that could be described.  Nevertheless, the “flu vaccine causes miscarriage” conspiracy has been thoroughly debunked by research, but still the internet meme continues.  Pseudoscience sometimes uses the same methodology (or lack of methodology) to make positive assertions.  Homeopaths will claim that their dilutions will cure whatever disease, yet they do not have scientific evidence supporting them, but there plenty of evidence that debunks what they practice.

As part of my analysis of medical claims of causation or “cures”, I often use this logic to test the possibility of the usefulness of any alternative medicine–is there any physical, chemical or biological mechanism that will allow the quack procedure to work?  If you cannot imagine it without violating some of the basic laws of science, then we should stand by Occam’s razor, which states often times the simplest solution is the best.  So, if there is no evidence of vaccinations being correlated, let alone causal, to autism, then that remains the simplest solution.  To explain a possible tie without any evidence would require us to suspend what we know of most biological processes.

As I’ve said in other posts, the internet gives us so much information, we tend to value it equally, as if every website provides accurate and logical data points.  Maybe you have a friend who had a miscarriage 24 hours after receiving the swine flu vaccine.  Maybe you’ve heard that many people have.  But that’s not science, that’s just a subjective observation.  Or even confirmation bias.

Once again, Dr. Novella says it perfectly:

In conclusion, correlation is an extremely valuable type of scientific evidence in medicine. But first correlations must be confirmed as real, and then every possible causational relationship must be systematically explored. In the end correlation can be used as powerful evidence for a cause and effect relationship between a treatment and benefit, or a risk factor and a disease. But it is also one of the most abused types of evidence, because it is easy and even tempting to come to premature conclusions based upon the preliminary appearance of a correlation.

 

Legal thuggery, antivaccine edition, part 3: Andrew Wakefield rallying the troops : Respectful Insolence

Legal thuggery, antivaccine edition, part 3: Andrew Wakefield rallying the troops : Respectful Insolence.

The arrogant, narcissistic Andrew Wakefield is going to bring  a lawsuit against Brian Deer, the dogged Times of London reporter who not only uncovered that the original Lancet article authored by Wakefield was filled with errors, but uncovered fraud committed by Wakefield.

This is just wrong.

How pseudoscience makes its case. Part 2.

Recently, I discussed how science works. It’s not a belief. It’s not a random set of rules. It is a rational and logical process to determine cause and effect in the natural world. Pseudoscience, by its very nature, ignores the scientific process; instead, it claims to come to conclusions through science, usually by using scientific sounding words, but actually avoids the scientific process.  They tend to use logical fallacies to make their case.  Just to be clear, logical fallacy is essentially an error of reasoning. When a pseudoscientist  makes a claim, or attempts to persuade the public of this claim, and it is based on a bad piece of reasoning, they commit a fallacy.

There are several types of logical fallacies that they employ.  My favorites are Appeals to Antiquity, or old ideas are somehow better than new ideas; Appeals to Authority, or someone who should know better supports the claim even if everyone else does not; Appeals to Popularity, or everyone does it, so it must be useful; and the Genetic Fallacy, where the source is more matter than the merits of the evidence.  Logical fallacies are so prevalent in skeptical community, there are websites devoted to describing them.

The typical pseudoscientist will use logical fallacies to state very definitively that “it’s proven.” It’s the same whether it’s creationism (the belief that some magical being created the world some small number of years ago), alternative medicine (homeopathy, which is nothing but water, has magical properties to cure everything from cancer to male pattern baldness), or vaccine denialists (I’ve discussed this topic before, no need to belabor).  The worst problem is that in the world of the internet, if you google these beliefs, the number of websites and hits that seem to state that they are THE TRUTH overwhelm those that are more skeptical or critical.

So how can you tell the difference between science and pseudoscience in medicine? In medicine, we gather and analyze evidence in one of two ways.

Almost any medical product, device, drug or procedure must, by law, must studied in a Randomized Controlled Trial, which is sometimes called a clinical trial. Essentially, it is a scientific experiment, designed to test the hypothesis of whether the safety and efficacy of a particular medical product is better than a placebo. That is, does the medical product produce results better than doing nothing at all. This is the “gold standard” of investigation, and if the study does confirm the hypothesis, you can be assured it has a benefit to your life (although the degree may be subject to argument). Alternative medicine just doesn’t do this (most of their reasoning is that their beliefs just doesn’t fit into the clinical trial model), so their is no proof that their products work. A clinical trial usually has thousands of participants, and is done in a manner that the patient and the physician do not know who is and who is not receiving the treatment. The results are analyzed statistically and published in peer-reviewed journals. Furthermore, the results are reviewed and investigated by the FDA (and legal bodies in other countries), before a drug or device can be used by a physician. This is an expensive and time-consuming process, in which alternative medicine hardly ever participates.

Now it’s not ethical to test every medical hypothesis with a clinical trial. For example, we know that smoking is bad for your health. Yet, tobacco manufacturers love to insist that there has never been a clinical trial that makes this conclusion. The reason that is true is that it would be unethical to give one group of adults cigarettes for 20 years and another group nothing to see if one would die at a higher rate. So we use epidemiological studies to determine if we can see in a population whether a cause has an effect. We can review records of thousands of smokers to see what the effect will be. Once again, pushers of alternative medicine therapies have not published a study of all the patients who might have used their therapy and see the result. Epidemiology is a scientific process that is critical to preventative medicine–without it, we cannot know if some behavior or public health issue has a causal effect on health.

Remember, anecdotes (“my mother’s friend’s cousin’s daughter was cured by eating this leaf”) are not reasons to accept alternative medicine. Even anecdotes that try to sound like science (“90 out of 100 people think this leaf does work”) aren’t a reason to “believe” in a pseudoscience.

You might have heard that taking lots of Vitamin C helps prevent colds. It doesn’t. And that conclusions is supported by large clinical trials, so unless you are afflicted by scurvy, there’s no reason to take large doses of the vitamin. And that’s the difference between real science and pseudoscience.