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Nine Questions, Nine Answers.

This is not an easy blog to write.  Doctors Novella and Gorski want the entries to be formal, academic, referenced, with a minimum of snark.
For the most part I comply. But sometimes. Sometimes. It is hard, so hard, to not spiral into sarcastic diatribes over the writings that pass for information on the interwebs. I wish, sometimes, that I could be an irascible computer as well.
What brings on this particular bit of angst is a bit of whimsy on the Internet called “9 Questions That Stump Every Pro-Vaccine Advocate and Their Claims.”  by David Mihalovic, ND. Mr. Mihalovic identifies himself as “a naturopathic medical doctor who specializes in vaccine research.” However, just where the research is published is uncertain as his name yields no publications on pubmed.  BTW. I am a beer researcher.
The nine questions show up frequently on the interwebs, similar to questions on is to ask when you want to stump an evolutionist.  Like the supposed stumpers for evolution, the vaccine questions are grounded in either misinformation or laziness. Let’s go through them one at a time.
1. Could you please provide one double-blind, placebo-controlled study that can prove the safety and effectiveness of vaccines?
One trial? It took me 55 seconds to find 20211953, and that includes time to boot the browser and mis-spell the search terms.  Vaccine efficacy randomized placebo control trial gives 416 pubmed results; add safety to the search term, you 126 returns. The are easily more than one.  Of course, to find them you have to look.
Of course, I am a highly educated adult who constantly searches the web for medical information.  For hoots and giggles, I asked my 12 year old son, whose passions are basketball and filming comedy videos, to find me a reference that met the same criteria and I timed him.
22 seconds to find Randomized, Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba from the NEJM.
12 yo one,  Mihalovic 0.  Served.
As long as we are on the topic, since he evidently place great store in science, could Mihalovic please provide one double-blind, placebo-controlled study that can prove the safety and effectiveness of naturopathy?  I would be happy at this point to know you could do a pubmed search corruptly just to make me look the fool.
2. Could you please provide scientific evidence on ANY study which can confirm the long-term safety and effectiveness of vaccines?
Long term is vague. What is long term?  Smallpox disappeared in 1976 thanks to the vaccine.  I have not seem a case of smallpox in my medical career, which now on it’s 31st year. No reported long term toxicities and the eradication of smallpox seems to me reasonable evidence for long term effectiveness.
No vaccine is 100% in efficacy, and whether  infected naturally or by way of a vaccine, immunity wanes with time.  In  earlier times  people would be have their immunity boosted by exposure to disease and maintain their antibody levels.  It is not the initial infection that leads to better immunity from natural infections, as posited by some antivaccine people, but the the fact that people were constantly re-exposed to wild type disease.
It is interesting what is happening with shingles.  Everyone used to get chickenpox as a child, and then, as they raised their kids and grand kids, got re-exposed to the virus and boost their immunity. Currently, due to the chickenpox vaccine and a change in the way way children are raised, older adults are not getting exposed naturally to chickenpox, immunity is waning, and there is an increase in shingles in older adults.  Part of why they need the zoster vaccine.  http://www.journals.uchicago.edu/doi/abs/10.1086/651078
Clever conspiracy, huh?
Unless exposed to new infection, immunity, as measured by antibody levels directed against the infecting agent, can wane over time. That is to be expected.  The nice thing about the immune system, unlike water, is that it remembers the infection. It is primed so that if exposed again at a later date, it can almost instantly produce large amounts of antibody to nip an infection in the bud. So rather than prevent infection, in some people far removed in time from the vaccine, may instead have a shorter, less severe illness and be infectious not as long, thereby decreasing spread.
There is a nice review in the NEJM 1798383 on duration of immunity (first search in pubmed using duration of immunity vaccine, results in 17 seconds, including correcting typos.  Seriously, just how hard is it to find this information?  As would be expected, it depends on the disease and the vaccine (live better than killed). They estimated the half life for the varicella zoster virus immunity at 50 years, 200 years for measles and mumps, and 11 years for tetanus.  If you peruse the references, you can find other studies that show variable but sustained response to vaccines,  for example 90% maintain immunity to smallpox up to 75 years after vaccination. 12925846
Long term safety was more difficult, 5 years was the limit of time I could find safety studies, for the Hepatits B.  j med virol  65 2001Most vaccine toxicities are found in the first week after the inoculation and the studies follow most patients for a year.  Probably would not cut it as long term for Mihalovic.
BTW, could you please provide scientific evidence on ANY study which can confirm the long-term safety and effectiveness of naturopathy?
3.  Could you please provide scientific evidence which can prove that disease reduction in any part of the world, at any point in history was attributable to inoculation of populations?
Smallpox? Smallpox? Smallpox? Anyone? Smallpox? Buehler? Buehler?
Again I get back to the whole binary, black and white approach that characterizes many with whom we cross medical swords.  The decrease in infectious diseases has been multifactorial, due to improved nutrition, improved hygienic (lets hear it for the flush toilet) and understanding the epidemiology of diseases.  Knowing how a disease is spread has always been critical in decreasing its spread.  Note that none, none, none of the interventions that have decreased the spread of infections in the last 200 years or so have come from alt med tradition.
The teasing out the effects of vaccines on populations is always fraught with potential controversy. There are always multiple confounders.  The best example of the effects of vaccines was from JAMA http://jama.ama-assn.org/cgi/content/full/298/18/2155
“Objective  To compare morbidity and mortality before and after widespread implementation of national vaccine recommendations for 13 vaccine-preventable diseases for which recommendations were in place prior to 2005.
Design, Setting, and Participants  For the United States, prevaccine baselines were assessed based on representative historical data from primary sources and were compared to the most recent morbidity (2006) and mortality (2004) data for diphtheria, pertussis, tetanus, poliomyelitis, measles, mumps, rubella (including congenital rubella syndrome), invasive Haemophilus influenzae type b (Hib), acute hepatitis B, hepatitis A, varicella, Streptococcus pneumoniae, and smallpox.
Main Outcome Measures  Number of cases, deaths, and hospitalizations for 13 vaccine-preventable diseases. Estimates of the percent reductions from baseline to recent were made without adjustment for factors that could affect vaccine-preventable disease morbidity, mortality, or reporting.
Results  A greater than 92% decline in cases and a 99% or greater decline in deaths due to diseases prevented by vaccines recommended before 1980 were shown for diphtheria, mumps, pertussis, and tetanus. Endemic transmission of poliovirus and measles and rubella viruses has been eliminated in the United States; smallpox has been eradicated worldwide. Declines were 80% or greater for cases and deaths of most vaccine-preventable diseases targeted since 1980 including hepatitis A, acute hepatitis B, Hib, and varicella. Declines in cases and deaths of invasive S pneumoniae were 34% and 25%, respectively.”
Milhalovic,  could you please provide scientific evidence which can prove that disease reduction in any part of the world, at any point in history was attributable to naturopathy?
4. Could you please explain how the safety and mechanism of vaccines in the human body are scientifically proven if their pharmacokinetics (the study of bodily absorption, distribution, metabolism and excretion of ingredients) are never examined or analyzed in any vaccine study?
There is, superficially, some truth in this statement.  Most pharmacokinetics are done prior to the clinical efficacy trials.  That is why there are phase 1 and phase 2 trials. The assumption being that if you exam influenza vaccine pharmacokinetic studies in one group it can be extrapolated to similar populations.  I think that is reasonable. So no, there are no pharmacokinetic studies in the clinical efficacy trials, those were done prior to the efficacy trials.  But it is not hard to find the phase 1 and 2 trials if you are so moved.
Milhalovic, could you please explain how the safety and mechanism of naturopathic nostrums in the human body are scientifically proven if their pharmacokinetics (the study of bodily absorption, distribution, metabolism and excretion of ingredients) are never examined or analyzed in any naturopathic nostrum study?  Is this getting old?  There is something to be said for repetition.
5. Could you please provide scientific justification as to how injecting a human being with a confirmed neurotoxin is beneficial to human health and prevents disease?
I presume the issue is mercury. Maybe aluminum. The latter is not in most vaccines, although as been discussed at length on this blog, the amount of mercury and aluminum found in vaccines is minimal and, at the dosing and formulation, has never been demonstrated to cause neurotoxicity from vaccines.  Of course, I am old school and think there is a dose response, and that a greater amount leads to a greater response.  Most naturopaths receive extensive training in homeopathy, where the less the amount, the greater the response.  So I would presume arguments based on chemistry would have little meaning to an ND, although I would not want my appletini made by a practitioner of homeopathy.
Of course, it is not the ‘neurotoxin’ that is being used to prevent disease, but the antigens of the potential infection. That is assuming that the author of the nine questions does not consider the antigens to be neurotoxins, and to judge from his understanding of disease later in the post, I am notes certain he warrants the benefit of the doubt.
Could you please provide scientific justification as to how applying naturopathy to a human being is beneficial to human health and prevents disease?
6. Can you provide a risk/benefit profile on how the benefits of injecting a known neurotoxin exceeds its risks to human health for the intended goal of preventing disease?
Since there is no more mercury in most vaccines, I will assume, for the sake of argument, it is the aluminum.  Risk from aluminum in the H. influenza type b vaccine, where aluminium is used as a adjuvant: zero.
The benefit from the vaccine: “From eight trials, the protective efficacy of the Hib conjugate vaccine was 84% (OR 0.16; 95%CI 0.08-0.30) against invasive Hib disease, 75% (OR 0.25; 95%CI 0.08-0.84) against meningitis, and 69% (OR 0.31; 95%CI 0.10-0.97) against pneumonia. Serious adverse events were rare.” 16491301
Seems a good trade off. No risk from aluminum, significant decrease in morbidity and mortality.
7. Could you please provide scientific justification on how bypassing the respiratory tract (or mucous membrane) is advantageous and how directly injecting viruses into the bloodstream enhances immune functioning and prevents future infections?
Well, things really get off the rails here.  Vaccines are not injected into the blood stream, they are infected into the soft tissues.   At a simple level, an infection enters to body, the body makes a variety of antibodies to the constituent parts of the infecting organism and next time the patient is exposed, the pre-existing antibody can, if there is a match with new strain, inactivate the new infection.
It doesn’t matter how the antigen is presented to the immune system, the response is the same. Natural influenza, inhaled influenza vaccine, or injected influenza vaccine, the same antibody will be made.
He says later
“All promoters of vaccination fail to realize that the respiratory tract of humans (actually all mammals) contains antibodies which initiates natural immune responses within the respiratory tract mucosa. Bypassing this mucosal aspect of the immune system by directly injecting viruses into the bloodstream leads to a corruption in the immune system itself. As a result, the pathogenic viruses or bacteria cannot be eliminated by the immune system and remain in the body, where they will further grow and/or mutate as the individual is exposed to ever more antigens and toxins in the environment which continue to assault the immune system.”
This is what we call in the trade, gibberish. At least it makes no sense to me.  I will leave to the readers to search, Bible Code style, for truthiness in the above selection.
8. Could you please provide scientific justification on how a vaccine would prevent viruses from mutating?
That is actually a very interesting question. It has nothing to do with why we give vaccines and  I fear our intrepid ND does not have a firm grasp on what he is talking about as he says
“Despite the injection of any type of vaccine, viruses continue circulating through the body, mutating and transforming into other organisms. The ability of a vaccine manufacturer to target the exact viral strain without knowing its mutagenic properties is equivalent to shooting a gun at a fixed target that has already been moved from its location. You would be shooting at what was, not what is!”
Mutating and transforming into other organisms. Sigh.  Either the author is a sloppy writer  (sloppy writing reflects a sloppy mind) or his understanding of microbiology is so profoundly mistaken it boggles the mind that he takes care of patients.  And in Oregon he would allowed by the state to prescribe antibiotics.
If you have a population of viruses and a specific antibody against the virus, then those naturally occurring mutants that are not recognized by the antibody should have a replication advantage.  It is possible that the vaccine can help select for new strains of an infection, but not new organisms.
Vaccines selecting for new mutants has been looked at for the Hepatitis B vaccine, and found not to be a issue 20210630.
In HIV, there is an ongoing interaction between the immune response and the virus driving mutations that escape the immune system and, in some patients leads to a marked increase in HIV replication and a clinical decline decline (9143689). Oh wait, this is a natural infection. That shouldn’t happen.  It is the vaccines that do do this.
There is nothing unique about the vaccine response acting as environmental pressure on the evolution of infections; the response from the natural infections should be the same.  I would wonder, since the response to  a natural infection is broader, with antibodies made to numerous parts of the infection, rather than the few key antibodies provided by the response to the vaccine, whether a natural infection would lead to a faster mutation rate.  As a rule in the microbial world, the more intense the stress, the faster and more varied the mutations.  More antibiotics leads to faster development of resistance in E. coli, not its delay
9. Could you please provide scientific justification as to how a vaccination can target a virus in an infected individual who does not have the exact viral configuration or strain the vaccine was developed for?
Dr. Black and White.  Antibody response is not all or nothing, there is a gradient of response between the developed antibody and the site to which it is directed.  A good example is the H1N1 influenza.  People exposed to the strains from the first half f the century had antibody that was partially protective for the 2009 strain.  The reason http://www.ncbi.nlm.nih.gov/pubmed/20049332?
“The pandemic influenza virus (2009 H1N1) was recently introduced into the human population. The hemagglutinin (HA) gene of 2009 H1N1 is derived from “classical swine H1N1″ virus, which likely shares a common ancestor with the human H1N1 virus that caused the pandemic in 1918, whose descendant viruses are still circulating in the human population with highly altered antigenicity of HA. However, information on the structural basis to compare the HA antigenicity among 2009 H1N1, the 1918 pandemic, and seasonal human H1N1 viruses has been lacking. By homology modeling of the HA structure, here we show that HAs of 2009 H1N1 and the 1918 pandemic virus share a significant number of amino acid residues in known antigenic sites, suggesting the existence of common epitopes for neutralizing antibodies cross-reactive to both HAs. It was noted that the early human H1N1 viruses isolated in the 1930s-1940s still harbored some of the original epitopes that are also found in 2009 H1N1. Interestingly, while 2009 H1N1 HA lacks the multiple N-glycosylations that have been found to be associated with an antigenic change of the human H1N1 virus during the early epidemic of this virus, 2009 H1N1 HA still retains unique three-codon motifs, some of which became N-glycosylation sites via a single nucleotide mutation in the human H1N1 virus. We thus hypothesize that the 2009 H1N1 HA antigenic sites involving the conserved amino acids will soon be targeted by antibody-mediated selection pressure in humans. Indeed, amino acid substitutions predicted here are occurring in the recent 2009 H1N1 variants. The present study suggests that antibodies elicited by natural infection with the 1918 pandemic or its early descendant viruses play a role in specific immunity against 2009 H1N1, and provides an insight into future likely antigenic changes in the evolutionary process of 2009 H1N1 in the human population.”
Oops.  Not simple.
But the result? http://www.ncbi.nlm.nih.gov/pubmed/20059763
” over 75% of confirmed cases of novel H1N1 occurred in persons < or = 30 years old, with peak incidence in the age range 10-19 years. Less than 3% of cases occurred in persons over 65, with a gradation in incidence between ages 20 and 60 years.The sequence data indicates that novel H1N1 is most similar to H1N1 viruses that circulated before 1943. Novel H1N1 lacks glycosylation sites on the globular head of hemagglutinin (HA1) near antigenic regions, a pattern shared with the 1918 pandemic strain and H1N1 viruses that circulated until the early 1940s. Later H1N1 viruses progressively added new glycosylation sites likely to shield antigenic epitopes, while T-cell epitopes were relatively unchanged.
CONCLUSIONS: In this evolutionary context, Original Antigenic Sin exposure should produce an immune response increasingly mismatched to novel H1N1 in progressively younger persons. We suggest that it is this mismatch that produces both the gradation in susceptibility and the unusual toxicity”
The better the antibdy fit for the epitope (where the antibody binds) the better the effect, but it doesn’t have to be all or nothing. He would probably ask, what good is half and eye, why have half a wing. Or had a brain.
He finishes
“I have never encountered one pro-vaccine advocate, whether medically or scientifically qualified, who could answer even 1 let alone all 9 of these questions. One or all of the following will happen when debating any of the above questions:
- They will concede defeat and admit they are stumped.
- They will attempt to discredit unrelated issues that do not pertain to the question.
- They will formulate their response and rebuttal based on historical arguments and scientific studies which have been disproved over and over again. Not one pro-vaccine advocate will ever directly address these questions in an open mainstream venue.”
I am neither stumped not defeated.
My response was not unrelated.
My arguments are bases on modern studies that a 12 year old can find in less than a minute.
SBM is an open mainstream venue.
I do feel like I just had a foot race with a sloth; where is the honor in that?
And people wonder why I question the wisdom of allowing naturopaths to function as primary care providers.

This is not an easy blog to write.  Doctors Novella and Gorski want the entries to be formal, academic, referenced, with a minimum of snark.

For the most part I comply. But sometimes. Sometimes. It is hard, so hard,  not to spiral into sarcastic diatribes over the writings that pass for information on the interwebs. How should one respond to profound ignorance and misinformation?  I wish, sometimes, that I could be an irascible computer as well.

What brings on this particular bit of angst is a bit of whimsy on the Internet called “9 Questions That Stump Every Pro-Vaccine Advocate and Their Claims.”  by David Mihalovic, ND. Mr. Mihalovic identifies himself as “a naturopathic medical doctor who specializes in vaccine research.” However, just where the research is published is uncertain as his name yields no publications on Pubmed.  BTW. I specialize in  beer research.  Same credentials.

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NDE Update

Back in 2008 I wrote on Near Death Experiences (NDE’s). I have an interest in this topic as I have frequent exposure to near death; my wife has a predilection for watching Judge Judy. Since 2008 there have been a few studies on the topic of NDEs as researchers try and find evidence that consciousness transcends the brain, if that is what a NDE represents. I have also been ill for most of the last week and have not had the usual time to spend generating typos to drive some readers to distraction. Fortunately, I have a miracle cure that is 100% effective in resolving all my self-limited illnesses: time. It passed and with it the illness. As a result I am about 10 days behind in the commitments in my life, so this will be a shorter than usual post.

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Outbreaks

There have been, in the last 20 years, natural, or perhaps unnatural, experiments that have helped shed light on the efficacy of vaccines.  Many societies, for reason of political unrest, religion, or a lack of understanding of science and medicine have seen the rates of vaccination decline and, with that decline, an increase in the cases of vaccine-preventable diseases.

Infectious disease spread in populations is not simple.  Hygiene, nutrition, access to health care, and education all play a role in the spread of communicable diseases.  Vaccines have been critical in driving the rates of vaccine preventable illnesses to almost zero, but they are not the only intervention in our armamentarium. (more…)

Posted in: Public Health, Vaccines

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Just the Facts

Get your facts first, and then you can distort them as much as you please.

—Mark Twain

There is an educational approach to becoming a doctor. It involves learning massive amounts of basic science, followed by massive amounts of pathophysiology, which barely prepares you for the clinical years of the last half of medical school and subsequent residency, with the massive knowledge dump you will have to absorb. Much of the information is given by experts in the field, usually MDs or PhDs (or both), who lecture formally and informally. Being considered an expert in infectious disease (ID) at a teaching hospital, I now spend hours a day yammering on about infections to anyone who will listen, students in all the medical fields who rotate through our hospitals. I value the facts I have learned in my field and respect those who have worked to provide me with the information. I greatly value facts and the people who provide them.

Most of the information I get in medicine is from those in the field. It is rare for people to write about aspects of medicine that I will take seriously. Yes, there are a lot of people who write on the web about medicine, but given what it takes to achieve even a solid knowledge in medicine, much less develop expertise, I usually can’t take them too seriously. Call me arrogant, but if you want to be a legitimate source of information there are dues that have to be paid.

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Posted in: Science and Medicine, Vaccines

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Changing Climate, Changing Infections

I will state my bias up front.  I am convinced by the preponderance of data in favor of man made global warming.  At the most simplistic level, I can’t see how converting humongous tons of fossil fuel into C02 and dumping it into the the atmosphere cannot have effects on the climate.  To my mind its like determining vaccine efficacy or evolution.  Plausible mechanism(s), good basic science, multiple studies using different lines of evidence that all come to the same conclusion.  There are lots of fine points and nuances to be worked out, but the basic truth is reasonable and well defined. Infectious diseases lend some validation to the concept that world is warming, since with global warming will come a variety of infectious diseases.
It is one big IF THEN statement.  IF global warming, THEN infections.  Of course the if the IF is not true, then the THEN doesn’t follow.
There is the weather, which the Action Channel News never seems to get right, and I will spare you the Mark Twain quote even though I think he is our best writer ever,  and there is the climate, the summation of weather over time.
Interestingly, infections have probably altered climate for short periods of times.  Through history humans burned trees releasing C02, chopped down forests for agriculture and raised animals, releasing methane.  As humans populations increased, both C02 from burning and methane from animals increased as well.  Every now and then large numbers of people have died off.  It happen when Columbus et. al. brought infections to the New World and when plague came to the Old.  People died.  Maybe 90% in the Americas (estimates vary widely) and 2/3′s of Europe died.  As a result, burning and agriculture decreased, decreasing emissions and forests grew back, sequestering C02.  And temperature rise slowed or decreased (http://stephenschneider.stanford.edu/Publications/PDF_Papers/Ruddiman2003.pdf).
“Abrupt reversals of the slow CO2 rise caused by deforestation correlate with bubonic plague and other pandemics near 200-600, 1300-1400 and 1500-1700 A.D. Historical records show that high mortality rates caused by plague led to massive abandonment of farms. Forest re-growth on the untended farms pulled CO2 out of the atmosphere and caused CO2 levels to fall. In time, the plagues abated, the farms were reoccupied, and the newly re-grown forests were cut, returning the CO2 to the atmosphere…Moreover, if plague caused most of the 10-ppm CO2 drops… it must also have been a major factor in the climatic cooling that led from the relative warmth of 1000 years ago to the cooler temperatures of the Little Ice Age.”
Like all good scientists, he notes the problems with his conclusions
“A more complete assessment of the role of plague- driven CO2 changes in climate change during the last millennium would require a narrowing of uncertainties in both the spatial and temporal occurrence of plague and in the amount of farm abandonment (and reforestation), as well as a resolution of the inconsistencies among the CO2 trends from different Antarctic ice cores.”
This kind of study will never be reported in the Atlantic; too much nuance.
It is not the correction for global warming I would suggest, an Earth Abides die off of humans.  But it is an fascinating association between infectious human deaths and global warming.
As the weather changes, for a week, a season, or a over longer period of time, the incidence and distributions of  infections change.  Infections could increase or decrease due to something as simple as temperature or humidity.
Or it could be more complex.  Increase rainfall could lead to more food, which could lead to a boom in the rodent population leading to more interactions of humans and mice and the next thing you know you have bubonic plague in India or Hanta virus outbreak in the four corners of the US.
The daily weather makes a difference in infection risk.  My favorite example is Legionella pneumonia, which increases shortly after thundershowers and humid weather.  It explains why we do not have a lot of Legionella in the NW despite all the rain; it is rarely hot and humid.
In Philadelphia  Legionella
“Cases occurred with striking summertime seasonality. Occurrence of cases was associated with monthly average temperature (incidence rate ratio [IRR] per degree Celsius, 1.07 [95% confidence interval [CI], 1.05-1.09]) and relative humidity (IRR per 1% increase in relative humidity, 1.09 [95% CI, 1.06-1.12]) by Poisson regression analysis. However, case-crossover analysis identified an acute association with precipitation (odds ratio [OR], 2.48 [95% CI, 1.30-3.12]) and increased humidity (OR per 1% increase in relative humidity, 1.08 [95% CI, 1.05-1.11]) 6-10 days before occurrence of cases.”
I ask the housestaff to look for Legionella after thundershowers and I usually get a case or two, although it may just be due to increased diagnostic testing.
Can you catch a cold when the weather is cold? Maybe.  It has been a topic of interest for years (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2279651/)
“The average outdoor temperature decreased during the preceding three days of the onset of any RTIs, URTI, LRTI or common cold. The temperature for the preceding 14 days also showed a linear decrease for any RTI, URTI or common cold.  (http://www.ncbi.nlm.nih.gov/pubmed/18977127).”
More interesting are the infections associated with El Nino oscillations, where the ocean temperatures vary on a 3 to seven to year cycle, leading to alternating wet and dry weather.  As a result
“In North America, El Niño creates warmer-than-average winters in the upper Midwest states and the Northwest, thus reduced snowfall than average during winter. Meanwhile, central and southern California, northwest Mexico and the southwestern U.S. become significantly wetter while the northern Gulf of Mexico states and Southeast states (including Tidewater and northeast Mexico) are wetter and cooler than average during the El Niño phase of the oscillation. Summer is wetter in the intermountain regions of the U.S. The Pacific Northwest states, on the other hand, tend to experience dry, mild but foggy winters and warm, sunny and early springs.”
Changes due to the El Nino lead to changes in the incidence of a huge variety of infections: an example, I think, from WHO.
Climate change will affect the distribution of disease vectors such as insects and snails.  Vectors may thrive with increased temperatures or they may die off, but more likely the vectors, like mosquitos, will move.  It has been estimated that half of everyone who has every died has died from a mosquito borne illness (I admit I heard this numoerous times at ID lectures but do not have reference, at least there is a solution . http://mashable.com/2010/02/12/mosquito-death-ray-video/).  As it gets warmer, mosquitos can either go up in elevation or North.  It seems that they are doing both.
- Dengue has appeared at higher altitudes than previously reported in Costa Rica (at 1,250m),and in Colombia and India (at 2,200m).The previous range was temperature limited to approximately 1,000 metres above sea level.
- In Mexico, the dengue vector (Aedes aegypti) has been detected at 1,600 metres; transmission of dengue was unknown above 1,200m before 1986. There have been cases of dengue near or above the altitude or latitude limit of transmission and would be vulnerable to the small increases in temperature that have occurred across these regions.
- Other examples of climate-related changes in the prevalence or distribution of pathogens and their vectors include the resurgence of Mediterranean spotted fever in Spain and Italy, the recent epizootic of African horse sickness in Iberia,the resurgence of plague in parts of southern Africa,increased incidence and geographic spread of algal blooms, outbreaks of opportunistic infections among seals,and the spread and establishment of pathogens and vectors in Switzerland.  http://archive.greenpeace.org/climate/impacts/erwin/3erwin.html
- Dengue has, by serology, infected 40% of the populations of Brownsville Texas, as the disease slowly moves north.
“In the fall of 2004, during a period of endemic dengue transmission, a cross-sectional survey was conducted in these two cities,4 and dengue incidence and prevalence were measured. In Brownsville, the incidence was 2%, which, if extrapolated to the 2005 population of the city (using the 95% confidence interval), projected between 837 and 5,862 recent infections. Similarly, the prevalence was 40%, with a range from 56,948 to 75,372; these values are relatively similar to those obtained from Brownsville in 2005. http://www.ajtmh.org/cgi/content/full/78/3/361″
More than mosquito born illnesses are changing in prevalence.  Hanta is increasing in Belgium.  There has been increased temperature which has lead to increased broadleaf trees, with increased seeds, with increased voles, which carry Hanta, which infected humans to cause renal failure (http://www.ij-healthgeographics.com/content/8/1/1).
Oceans are getting warmer and supporting infections.  Vibrio was not found in Alaskan oysters as the water was too cold.  The water temperature was always less than 15 C.  No longer.  The mean temperature has increased each year since 1997  and now supports the growth of V. parahaemolyticus with resultant outbreaks (http://content.nejm.org/cgi/content/abstract/353/14/1463).  Many other infectious diseases are increasing as well http://www.thebulletin.org/web-edition/columnists/laura-h-kahn/the-threat-of-emerging-ocean-diseases.
However, not all is doom and gloom.  Some infections may fade with global warming. For example, RSV may be disappearing as England warms.
“The seasons associated with laboratory isolation of respiratory syncytial virus (RSV) (for 1981–2004) and RSV‐related emergency department admissions (for 1990–2004) ended 3.1 and 2.5 weeks earlier, respectively, per 1°C increase in annual central England temperature ( and .043, respectively). Climate change may be shortening the RSV season. http://www.journals.uchicago.edu/doi/abs/10.1086/500208.”
Diseases that may increase in the US or become endemic again include malaria, dengue, and Leishmaniasis.  A 4 degree rise in temperature could allow dengue to exist as far north as Winnipeg and malaria to be in all of Europe. Seems to be a good trade off to me: more dengue and malaria, less RSV.
Good times for an infectious disease doctor.
These studies are representative of the literature, not a comprehensive review of the topic.  Personally, I find this adjunctive data compelling  support of global warming, at least over recent times (deliberately worded to not commit to the meaning of recent.)  This does not include all the other potential interactions between human behaviors and changes in the weather to result in an increase in infectious diseases.  Even simple local changes can lead to the unexpected increase in the risk of diseases.
“Adjustable rate mortgages and the downturn in the California housing market caused a 300% increase in notices of delinquency in Bakersfield, Kern County. This led to large numbers of neglected swimming pools, which were associated with a 276% increase in the number of human West Nile virus cases during the summer of 2007.”   http://www.cdc.gov/eid/content/14/11/1747.htm
All the neglected pools became mosquito breeding grounds, and the disease spread was exacerbated in part by a drought that altered bird populations from resistant finches to susceptible sparrows that were not immune to west nile, allowing the disease to spread.  The result, I suppose, of failed flock immunity.
Imagine how war, human migration, starvation will interact with climate change to increase or alter the spread of malaria, Tb and some infection that no one can predict.  If H1N1 proved anything, it is whatever new infection will sweep  across the county, it will not be the infection we predict. Who would have thought in 1989 that the next decade would see West Nile virus, never seen the the US, arrive to the continent in a migrating goose and become endemic.
Maybe its just the weather, the season, or the climate.  I think these are a few interesting infectious disease associations that lend credence to climate change.

“Conversation about the weather is the last refuge of the unimaginative.” – Oscar Wilde

I will state my bias up front.  I am convinced by the preponderance of data in favor of man made global warming.  At the most simplistic level, I can’t see how converting humongous tons of fossil fuel into CO2 and dumping it into the the atmosphere cannot have effects on the climate.  To my mind its like determining vaccine efficacy or evolution.  Plausible mechanism(s), good basic science, multiple studies using different lines of evidence that all come to the same conclusion.  There are lots of fine points and nuances to be worked out, but the basic truth is reasonable and well defined. Infectious diseases lend some validation to the concept that the world is warming, since with global warming comes a variety of infectious diseases.

It is one big IF:THEN statement.  IF global warming, THEN infections.  Of course  if the IF is not true, then the THEN doesn’t follow.

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Changing Your Mind

Why is my mind so clean and pure?  Because I am always changing it.
In medical school the old saying is that half of everything you learn will not be true in 10 years, the problem being they do not tell which half.
In medicine, the approach is, one hopes, that data leads to an opinion.  You have to be careful not to let opinion guide how you evaluate the data.  It is difficult to do, and I tell myself that my ego is not invested my interpretation of the data. I am not wrong, I am giving the best interpretation I can at the time. For years  I yammered on about how it made no sense to give a beta-lactam and a quinolone for sepsis until a retrospective study suggested benefit of the combination.  Bummer. Now when I talk to the housestaff about sepsis, I have to add a caveat about combination therapy.  It is why my motto is, only half jokingly,  ”Frequently in error, never in doubt”.
At what point do you start to change you mind?  Alter your message as a teacher?  Have new behavior?  Medicine is not all or nothing, black and white.  Changes are incremental, and opinions change slowly, especially if results of a new study contradict commonly held conclusions from prior investigations.
Nevertheless, I am in the process of changing my mind, and it hurts.  I feel like Mr. Gumby. (http://www.youtube.com/watch? v=IIlKiRPSNGA)
It is rare that there is one study that changes everything; medicine is not an Apple product.  Occasionally that there is a landmark  study that alters practice in such a dramatic way that there is a before and after.  As I write this I cannot think of a recent example in infectious diseases, but I am sure there is one.  The problem is that once practice changes, it seems as we have always done it that way.
For me, three is the magic number.  One study that goes against received wisdom warrants an ‘interesting, but give me more.”
Two studies, especially if using different methodologies with the same results gives and ‘well, two is interesting, but I can argue against it.”  However, with two studies the seed of doubt is planted, waiting to be watered with the water of further confirmation.  Yeah. Bad metaphor.
Three studies with different methodologies independently confirming new concepts?  Then I say, “I change my mind. My brain hurts.”
There are now three studies concerning the issue of efficacy of the flu vaccine in the elderly.  You might remember my discussion of the Atlantic article several months ago. In that entry I discussed two articles  that suggested the flu vaccine may be less effective in the elderly than the studies demonstrated. http://www.sciencebasedmedicine.org/?p=2495
The argument was that the elderly who received the influenza vaccine were healthier at baseline than those that didn’t receive the vaccine and the deaths during flu season was not due to the protection from the vaccine, but due to the fact that healthier people are less likely to die when they get ill. In part this was demonstrated by showing decreased deaths in vaccinated populations when influenza was not circulating.  If insomnia is a problem, you can go back and read my post.   To quote my favorite author, me, I said
“One, it is an outlier, and outliers need confirmation. The preponderance of all the literature suggests that influenza vaccine prevents disease and death. If you do not get flu, you cannot die from flu or flu related illnesses. When outliers are published, people read them, think, “huh, that’s interesting”, but there is going to have to be more than one contradictory study to change my practice. But if “study after study” shows mortality benefit, and one study does not, it is food for thought, but not necessarily the basis of changing practice. The results, above all, needs to be repeated by others… In medicine we tend to be conservative about changing practice unless there is a preponderance of data to suggest a change is reasonable. Except, of course, if our big pharma overlords take us to a good streak house.”
Now we have a third article, “Evidence of Bias in Studies of Influenza Vaccine Effectiveness in Elderly Patients” from the Journal of Infectious Diseases.
In the study they examined the records of the elderly in the Kaiser Health System, their vaccination records, and their risk of death.  And the results were interesting.
“The percentage of the population that was vaccinated varied with age. After age 65, influenza vaccination increased until age 78 in women and age 81 in men, then decreased with increasing age. Vaccination coverage also varied in a curvilinear fashion with risk score, increasing with risk score to a risk score percentile of ∼80%, then decreasing. In addition, as the predicted probability of death increased, vaccination coverage increased. Vaccination coverage was highest among members with a probability of death of 3%–7.5%. Those with a predicted probability of death in the coming year of 17.5% had a de- creasing likelihood of influenza vaccination”
They then looked at mortality when flu was not circulating.
“A change in the pattern of vaccination had a striking effect on mortality. For members > 75 years old who had been receiving influenza vaccinations in previous years, not receiving a seasonal influenza vaccination was strongly associated with mortality in the months ahead (Table 1). A person who had received an influenza vaccination every year in the previous 5 years had a more than double probability of death outside the influenza season if he or she missed a vaccination in the current year, compared with a person who was vaccinated as usual (odds ratio, 2.17; P < .001). On the other hand, if a person did not receive any seasonal influenza vaccination in the previous 5 years, then receipt of a vaccination in the current year was associated with a greater probability of death. “
If they had a history of flu vaccine for five years and missed it, the probability of death went up.
If they did not have a flu vaccine for five years and got one, the probability of death went up.
They suggest in the first case, the patients may have had an increase in their co-morbidities and as a result did not get the vaccine and died of underlying diseases. Their increased risk of death was from accumulating prior illnesses.
In the second case, people who were healthy and did not seek care subsequently developed diseases that lead them to a doctor who advised the vaccine.  Their increase risk of death was due to new illnesses.
Either way, the uptake of the flu vaccine is more complicated than I had suspected and makes interpretation of efficacy of the vaccine in prior studies harder to evaluate.  The table shows an unexpected relationship between age, risk of death and use of the flu vaccine.
table here
They say in the discussion
“We showed that, despite strong efforts to increase vaccination among the elderly population, vaccination is relatively low in the oldest and sickest portions of the population. Persons 65 years old with a 17.5% chance of death in the upcoming year are less likely to receive the influenza vaccine. Because persons who are most likely to die are less likely to receive the vaccine, vaccination appears to be associated with a much lower chance of dying; thus, the “effectiveness” of the vaccine is in great part due to the selection of healthier individuals for vaccination, rather than due to true effectiveness of the vaccine. Previous studies have argued that worsening health is associated with increasing vaccination. We found this to be a curvilinear relationship, in which increasing illness means increasing vaccination, up to a point, and then, as people come closer to the end of life, there is a decrease in vaccination coverage.”
They do not say the vaccine is not effective, but they suggest that there is a bias that may make the vaccine appear more effective in the elderly than it really is.  Reality is often more complex than one would think at the beginning.
After three studies I am reasonably convinced that efficacy of the flu vaccine in the elderly is potentially not as well understood as I had thought.
So do I think the flu vaccine is no longer useful in the elderly?  No.  I still think it is a reasonable intervention but it may not have the efficacy I would like.  But I have always known that, for a variety of reasons, the flu vaccine is not a great vaccine. But it is better than no vaccine. There are, as discussed in the earlier post on the vaccine, many lines of evidence to show that the flu vaccine has benefit; at issue is the degree of the benefit.  Perhaps what is needed is a better vaccine with adjuvants or multiple injections to get a better result in the elderly, who respond poorly to the vaccine.  Or perhaps it will be better to focus on increasing vaccination in those who care for or have contact with the elderly.  But when I talk to my patients and residents, when I get to part about flu vaccine efficacy, I will be a little more nuanced, use more qualifiers. I will tell them that the vaccine is like seat belts.  It does not prevent all death and injury, but if you had a choice, would you not choose to use seat belts?
In the end the data has to change the way I think about medicine, not matter how much it hurts.
Compare and contrast that with the anti-vaxers who have the belief that vaccines cause autism.  They look for data to support the pre-existing belief and ignore contrary data.  Opinion does not follow from data.
The most representative statement of their approach is on the 14 studies website where they say  ”“We gave this study our highest score because it appears to actually show that MMR contributes to higher autism rates.”
The key phrase in the whole site. Data that supports their position is good, data that does not is bad. What makes a study good is not its methodology or its rigor, or its reproducibility, or its biologic plausibility,  but if it supports vaccines casing autism.
Dr. Wakefield, as has been noted over the last week, had his MMR/autism paper withdrawn from Lancet not for bad science, but for dishonest science.  In medicine you can be wrong, but you cannot lie.  If the results of medical papers were shown to be fabrications, such as the papers of Scott S. Reuben, no one the medical field would defend the results.  Dr. Reuben, as you may remember http://www.sciencebasedmedicine.org/?p=408, was found to have fabricated multiple studies on the treatment of pain.  Nowhere can I find web sites defending his faked research.  No suggestions it was due to a conspiracy of big pharma to hide the truth. No assertions that he is still a physician of great renown.   He lied and is consigned to ignominy.   Physicians who used his papers as a basis of practice no longer do so, or so I would hope.
The response to Dr. Reuban is in striking contrast to the defense of Dr Wakefield, where bad research combined with unethical behavior, results in reactions like this
“It is our most sincere belief that Dr. Wakefield and parents of children with autism around the world are being subjected to a remarkable media campaign engineered by vaccine manufacturers reporting on the retraction of a paper published in The Lancet in 1998 by Dr. Wakefield and his colleagues.
The retraction from The Lancet was a response to a ruling from England’s General Medical Council, a kangaroo court where public health officials in the pocket of vaccine makers served as judge and jury. Dr. Wakefield strenuously denies all the findings of the GMC and plans a vigorous appeal.”
Opinions did not change when the Wakefield paper was demonstrated to be not just wrong but false, the researcher’s behavior unethical, and the study could not be reproduced using similar methodologies (http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0003140).  Instead, the defense of Dr. Wakefield became, well, like a Jim Carrey shtick. The Mask defends retracted autism research. Fire Marshall Bill on the medical literature.  Jenny and Jim’s defense does make more sense read as comic performance art.  Andy Kaufmann would have been proud.
I wonder if the more grounded in fiction an opinion is, the harder it is to change, the more difficult it is to admit error.  I have to admit I cannot wrap my head around the ability of people to deny reality.  It is the old Groucho line come to life, “Who are you going to believe, science or your lying eyes?”
So I will, I hope, keep changing my mind as new information come in.  It is what separates real health care providers from acupuncturists and homeopaths and naturopaths and anti-vaxers.  It is what some truly great minds admit to doing (http://www.edge.org/q2008/q08_index.html).  As one deeper thinker and better writer (http://www.emersoncentral.com/selfreliance.htm) than I said, kind of,
“The other terror that scares us from self-trust is our consistency; a reverence for our past act or word, because the eyes of others have no other data for computing our orbit than our past acts, and we are loath to disappoint them.
But why should you keep your head over your shoulder? Why drag about this corpse of your memory, lest you contradict somewhat you have stated in this or that public place? Suppose you should contradict yourself; what then? It seems to be a rule of wisdom never to rely on your memory alone, scarcely even in acts of pure memory, but to bring the past for judgment into the thousand-eyed present, and live ever in a new day. In your metaphysics you have denied personality to the Deity: yet when the devout motions of the soul come, yield to them heart and life, though they should clothe God with shape and color. Leave your theory, as Joseph his coat in the hand of the harlot, and flee.
A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines and anti-vaxers. With consistency a great soul has simply nothing to do. He may as well concern himself with his shadow on the wall. Speak what you think now in hard words, and to-morrow speak what to-morrow thinks in hard words again, though it contradict every thing you said to-day. — ‘Ah, so you shall be sure to be misunderstood.’ — Is it so bad, then, to be misunderstood?”

Why is my mind so clean and pure?  Because I am always changing it.

In medical school the old saying is that half of everything you learn will not be true in 10 years, the problem being they do not tell which half.

In medicine, the approach is, one hopes, that data leads to an opinion.  You have to be careful not to let opinion guide how you evaluate the data.  It is difficult to do, and I tell myself that my ego is not invested my interpretation of the data. I am not wrong, I am giving the best interpretation I can at the time. For years  I yammered on about how it made no sense to give a beta-lactam and a quinolone for sepsis until a retrospective study suggested benefit of the combination.  Bummer. Now when I talk to the housestaff about sepsis, I have to add a caveat about combination therapy.  It is why my motto is, only half jokingly,  ”Frequently in error, never in doubt”.

At what point do you start to change you mind?  Alter your message as a teacher?  Have new behavior?  Medicine is not all or nothing, black and white.  Changes are incremental, and opinions change slowly, especially if results of a new study contradict commonly held conclusions from prior investigations.

Nevertheless, I am in the process of changing my mind, and it hurts.  I feel like Mr. Gumby.

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The Tamiflu Spin

I will start, for those of you who are new to the blog, with two disclaimers.

First, I am an infectious disease doctor. It is a simple job: Me find bug. Me kill bug. Me go home. I spend all day taking care of patients with infections. My income comes from treating and preventing infections. So I must have some sort of bias, the main one being I like to do everything I can to cure my patients.

Second, in 25 years I have, to my knowledge, accepted one thing from a drug company. The Unisin (that’s how I spell it) rep, upon transfer from my hospital, sent me a Fleet enema with a Unisin sticker on it. I show it proudly to all who enter my office. I do not even eat the drug company pizza at conference, and I cannot begin to tell you painful that is.

As we leave (I hope) the H1N1 season and enter seasonal flu season, there has been a flurry of articles, originating in the British Medical Journal , questioning whether oseltamivir is effective in treating influenza. The specific complaint at issue is whether or not oseltamivir prevents secondary complications of influenza like hospitalization and pneumonia. Although you wouldn’t guess that was at issue from the reporting.  As always, there is what the data says, what the abstract says, what the conclusion says, and what other people say it says.  Reading the medical literature is all about blind men and elephants.

There is, evidently, going to be an investigation by the European Union Council of Europe  into whether or not the H1N1 pandemic was faked to sell more oseltamivir. Sigh.
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health, Science and the Media

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$10,000 reward not offered for scientific proof of supplements and alternative medicine therapies and effectiveness

Inspired by a post today

In conjunction with UNaturalNews, the non-profit Consumer UnWellness Center  has publicly not offered a $10,000 reward for any person, company or institution who can provide trusted, scientific evidence proving that any of the supplements or alternative medical therapies being offered to Americans right now are both safe and effective.

Supplement or alternative medical therapies promoters keep citing their “science” in claiming that supplements or alternative medical therapies are safe and effective. UnNaturalNews asks one simple question: Where is this science?

The $10,000 reward will not be issued to anyone who can produce scientific evidence meeting the following criteria: (more…)

Posted in: Herbs & Supplements, Humor, Vaccines

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You. You. Who are you calling a You You?

The YOU Docs, for those of you (YOU?) who are unaware, are Doctors Mehmet Oz and Mike Roizen, authors of books about YOU and a weekly newspaper column called The YOU Docs. It’s all about YOU.

There are two areas of the knowledge where I have more than passing understanding: infectious diseases and sCAMs. It always concerns me when I read nonsense in the few areas where I have some expertise. I have to wonder about the validity of other information in the paper like war and the economy. You know, important stuff. It could probably be argued that since the YOU Docs are in the “How We Live” section, the same section that carries horoscopes, the movie and TV reviews, the weather report — the fiction section — it should not taken seriously. After all, it is usually adjacent to the People’s Pharmacist, and my father always told me that you can judge a person by the company they keep.

The YOU Docs had a column with the headline: “Research backs acupuncture for a range of ills“. More fiction? Research backs acupuncture? News to me, but they are, after all, YOU Docs, and therefore may have information not accessible to mere docs with a small ‘d’. I grant up front to the authors that it is hard to be rigorous, or even coherent, in a 452 word essay. I am over 3,200 words for this entry. There are also no references, so I have to assume I found the correct research mentioned by the hints in the text.

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Causation and Hill’s Criteria

Causation is not so simple to determine as one would think. A mantra at SBM is ‘association is not causation’ and much of the belief in the efficacy of a variety of quack nostrums occurs because improvement occurs after use of a nostrum, therefore improvement occurs because of use of a nostrum. It is why vaccines as a cause of autism are so compelling to some. Vaccines are given at the same time autism starts to manifest. It would require more intellectual power than I have not to conclude, wrongly, that vaccines caused the autism. Concluding causation from sequential events is how the human mind works, and reality, as we know and ignore, constantly conspires to fool us into making false causal connections. In Infectious Diseases I see the error almost daily. The patient had a fever, patient was given antibiotics, fever went away. Therefore the antibiotics treated an infection. Well, maybe, maybe not. One of my mantras is ‘antibiotics are not antipyretics’ and you must be very careful before concluding that the fever went away because of the penacephalone. (more…)

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