Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

What Does the Approval of a Russian Vaccine Mean?



Today, after testing on a grand total of 76 people, President Putin announced the approval of a vaccine in Russia, Sputnik-V, to prevent COVID-19.

We knew another pandemic was coming, because we understand evolution. We should have been prepared. We were prepared under the Bush administration. We were prepared under the Obama administration. The current administration chose to stop wasting money on being prepared.

There are three human phases of testing generally required before the approval of a vaccine or drug, after testing in other animals. Phase I is testing in humans for common adverse effects, dosing ranges, and to generally learn how the body reacts. For the most discussed vaccine trial, Moderna had 45 people (three groups of 15 people each receiving different doses of vaccine) in their Phase I trial.

Phase II expands the use to people who are not as healthy as the people in Phase I and to a more people. Phase III is refining this, based on the results of the earlier trials. Phase I and II are being combined in some vaccine trials. Phase II and II are being combined in others.

The Moderna Phase III trial of mRNA-1273 (mRNA is messenger RiboNucleic Acid – the stock ticker for Moderna, Inc. is also MRNA) is expected to enroll 30,000 people who have no evidence of previous COVID-19 infection.[1] Half will get mRNA-1273 and half will get a meningitis vaccine as a placeboish control. While a placebo often means inert, a saline solution injection would not produce the temporary fever, soreness, and/or redness to the site at the same rate as an actual vaccine. This is expected to keep the volunteers from being able to tell which they have received and it provides a benefit to those in the placebo group.

Russia has enrolled 76 people in Phase I and President Putin has announced that Phase III will happen at the same time as the mass vaccination of the people most likely to be exposed to infection. This is Phase IV – post approval study.

Russia has not announced any challenge testing, which might have been a more ethical approach than skipping Phase III. Challenge testing has not being announced anywhere for COVID-19 vaccine testing, because of the ethical concerns. With an expected 1/2% to 1% fatality rate, a much higher rate of serious complications, and an unknown rate of long term complications that appear to be related to COVID-19, it is difficult to justify intentionally exposing people to infection with a vaccine of unknown ability to protect the people being exposed. Thousands of people dying each day, thousands more developing serious complications each day, and thousands more developing long term complications each day. Where is the line drawn between approving challenge testing and not approving it? Where is the line drawn between challenge testing and skipping Phase III trials?

When will the Russian vaccine be given to people? Some time in October.

What could go wrong?

Meanwhile the Moscow-based Association of Clinical Trials Organizations (Acto), which represents the world’s top drug companies in Russia, urged the health ministry to postpone approval until after phase-three trials.

Acto executive director Svetlana Zavidova told the Russian MedPortal site that a decision on mass vaccination had been carried out after a combined first- and second-phase tests on 76 people, and that it was impossible to confirm the efficacy of a drug on this basis.[2]

Will this be just another political intervention, like hydroxychloroquine? Only time will tell.

What would indicate that the United States has a safe and effective vaccine?

I want to see recommendation of a vaccine by the people who know the most about vaccines – Paul Offit, Michael Osterholm, Peter Hotez, and Anthony Fauci. They need to be able to see all of the evidence. The only reasonable conclusion about a refusal to share the evidence with any of them is that there is something bad being hidden. These are not politicians. None of these medical experts have shown signs of being influenced by political pressure.

The pandemic was not at all a surprise. The conspiracy theorists will misrepresent this video, because of their lack of understanding of what they are hearing. If it doesn’t support their prejudices, they don’t seem to hear anything at all, as if they have been programmed to ignore valid evidence and logic.

Pandemic Preparedness in the Next Administration: Keynote Address by Anthony S. Fauci – Feb. 14, 2017 – Almost 3 years before COVID-19, but the medically competent audience understood that this was a reasonable prediction to make in 2017. If you don’t understand that, watch the whole video.



Every reasonable person should have known there would be another pandemic, but we have media that discourage understanding, especially about science.


Late addition – 10:55 – 8/12/2020 – For further information, Carl Zimmer has an article in The New York Times going into more detail. A couple of important quotes from the article are below.

‘This Is All Beyond Stupid.’ Experts Worry About Russia’s Rushed Vaccine
August 11, 2020
by Carl Zimmer. Andrew Kramer and Katherine J. Wu contributed reporting.
The New York Times
Article

“This is all beyond stupid,” said John Moore, a virologist at Weill Cornell Medical College in New York City. “Putin doesn’t have a vaccine, he’s just making a political statement.”

Dr. Nicole Lurie, a former assistant secretary for preparedness and response at the U.S. Department of Health and Human Services and currently an adviser at the Coalition for Epidemic Preparedness Innovations, said the lesson that the U.S. government should draw from Mr. Putin’s announcement is clear.

“This is exactly the situation that Americans expect our government to avoid,” she said.

Footnotes:

[1] Phase 3 clinical trial of investigational vaccine for COVID-19 begins – Multi-site trial to test candidate developed by Moderna and NIH.
Monday, July 27, 2020
NIH (National Institutes of Health)
News Release

[2] Coronavirus: Putin says vaccine has been approved for use
Analysis by Fergus Walsh, Medical correspondent
BBC
Article

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Is Hydroxychloroquine Effective Against COVID-19?

     
As with any popular treatment, there are plenty of people who want us to ignore the research, or to focus on giving people hope. That is not a reasonable, or ethical, approach to medicine. That is not even a medical approach to medicine. If we lower our standards enough, we can claim that everything works, but that would kill a lot more people than only using treatments based on EBM (Evidence Based Medicine). Should we make excuses for lowering our standards, and killing people, or should we insist on raising our standards?

There is currently a pandemic, so there is a bit of a rush to find something that works, which some people mistake for a need to provide hope. If you want hope, you can pray and there should not be any harmful effects of praying. However knowing that you were being prayed for by others has been associated with a significantly higher incidence of complications. In other words, praying for yourself or others is fine, but telling others that you are going to pray for them is probably harmful, even though your intent is to help.[1]

The reasonable way to look at taking medicine is take only those treatments that have been demonstrated to improve outcomes for people with the studied diagnosis, when you have that diagnosis. Everything else is a crap shoot, where you don’t even know the risks – and there probably is no benefit.

Why do I state that the risks to the person taking the treatment are unlimited, but the benefits probably do not exist?

That is the history of the study of treatments. Almost everything proposed as a treatment has been more harmful than beneficial. It would be nice if this were not true, but reality doesn’t care about being nice. All of alternative medicine falls into the category of probably more harmful than safe and unlikely to be of any benefit, other than a benefit to the finances of the person selling the alt med.

Is hydroxychloroquine alternative medicine? Hydroxychloroquine is approved as real medicine for malaria, lupus erythematosus, and rheumatoid arthritis.[2] For these diagnoses, hydroxychloroquine is not alternative medicine. For everything else, the use is off-label, which is a legal way of saying alternative medicine, as far as the FDA (Food and Drug Administration) is concerned. Sometimes off-label use can be supported by good evidence, but the treatment has not been submitted to the FDA for approval for that diagnosis, but that is not the case with hydroxychloroquine. The FDA issued an EUA (Emergency Use Authorization) for hydroxychloroquine limited to adults and adolescents who weigh 50 kg (approximately 110 pounds) or more, who were hospitalized with COVID-19, and for whom participation in a clinical trial was not available, or participation was not feasible.[3]

Why are those limitations important?

1. If a treatment is effective, diverting patients from clinical trials will delay learning that the treatment is effective, which will significantly decrease the number of lives saved.

2. If a treatment is not effective, diverting patients from clinical trials will delay learning that the treatment is not effective, which will significantly decrease the number of lives saved, because patients are receiving a useless distraction from effective treatment.

3. If a treatment is harmful, which is much worse than just being not effective, diverting patients from clinical trials will delay learning that the treatment is harmful, which will significantly increase the number of patients killed.

All of those results – and those are the possibilities – are ignored by those who reject research. No treatment, however good, will be purely beneficial. All treatments have adverse effects. however, the reverse of that is not true. A treatment that is harmful often does not provide any benefit.

The odds are always against the patient. Any doctor trying to just do something is endangering patients. Kitchen sink medicine (throwing everything at the patient, just in case) has always been bad medicine.

There is a good discussion of the evidence in two podcasts:

15. Covid-19: Is There a Case for Hydroxychloroquine?
Stimulus with Rob Orman, MD (who also hosts the ERCast)
July 30, 2020
Podcast page

Dr. Orman does not specifically mention the Arshad study, which claims to show a benefit in patients treated with HCQ (HydroxyChloroQuine), AZM (AZithroMycin), and HCQ+AZM (HydroxyChloroQuine + AZithroMycin), but that does not change the conclusion of an examination of the evidence.[4]


COVID-19 Treatment Update: Can We Just Stop Wasting Time on Hydroxychloroquine
Written by Salim Rezaie
July 6, 2020
Podcast page

Here is the most important point from Salim Rezaie about the outcomes from the Arshad study:

As most patients in this trial receiving HCQ or HCQ + AZM received steroids and the patients receiving AZM alone or neither therapy had far fewer patients receiving steroids, the likely mortality benefit of this trial is due to the steroids and not the HCQ or HCQ + AZM


Dr. Rezaie concludes: This study should not change clinical practice of not prescribing these medications.

The Arshad study is being used by proponents of hydroxychloroquine alternative medicine to try to contradicting higher quality research, which is the reason it is not real medicine. When there is only low quality evidence, we should be cautious in recommending any treatment. When the high quality evidence shows that the low quality evidence is misleading, we should ignore the low quality evidence until there is high quality evidence to support the findings of the low quality evidence. Don’t expect that to happen.

The reason most medical research is overturned is the reliance on low quality evidence.[5], [6], [7], [8]


Footnotes:

[1] Study of the Therapeutic Effects of Intercessory Prayer (STEP) in cardiac bypass patients: a multicenter randomized trial of uncertainty and certainty of receiving intercessory prayer
Herbert Benson 1, Jeffery A Dusek, Jane B Sherwood, Peter Lam, Charles F Bethea, William Carpenter, Sidney Levitsky, Peter C Hill, Donald W Clem Jr, Manoj K Jain, David Drumel, Stephen L Kopecky, Paul S Mueller, Dean Marek, Sue Rollins, Patricia L Hibberd
Am Heart J. 2006 Apr;151(4):934-42. doi: 10.1016/j.ahj.2005.05.028.
PMID: 16569567

Our study had 2 main findings. First, intercessory prayer itself had no effect on whether complications occurred after CABG. Second, patients who were certain that intercessors would pray for them had a higher rate of complications than patients who were uncertain but did receive intercessory prayer.



[2] Hydroxychloroquine Sulfate tablet
INDICATIONS AND USAGE
Daily Med
FDA Label


[3] Frequently Asked Questions on the Revocation of the Emergency Use Authorization for Hydroxychloroquine Sulfate and Chloroquine Phosphate
FDA
Page as PDF download

Q. Why did FDA grant the EUA for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) for the treatment of COVID-19 initially?
A. On March 28, 2020, BARDA requested and FDA issued an Emergency Use Authorization (EUA) for emergency use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) for the treatment of COVID-19. Based on the scientific information available to FDA as of that date, the Agency determined that CQ and HCQ may be effective in treating COVID-19 and that the known and potential benefits of CQ and HCQ outweighed the known and potential risks for this use. The agency limited the use of authorized products to adults and adolescents who weigh 50 kg (approximately 110 pounds) or more, who were hospitalized with COVID-19, and for whom participation in a clinical trial was not available, or participation was not feasible.



[4] Treatment with hydroxychloroquine, azithromycin, and combination in patients hospitalized with COVID-19
Samia Arshad,a Paul Kilgore,b,c Zohra S. Chaudhry,a Gordon Jacobsen,e Dee Dee Wang,d Kylie Huitsing,a Indira Brar,a George J. Alangaden,a,c Mayur S. Ramesh,a John E. McKinnon,a William O’Neill,d Marcus Zervos,a,c,⁎ and Henry Ford COVID-19 Task Force1
Int J Infect Dis. 2020 Aug; 97: 396–403.
Published online 2020 Jul 2. doi: 10.1016/j.ijid.2020.06.099
PMID: 32623082

PMCID: PMC7330574 (Free Full Text from PubMed Central)


[5] Why Most Published Research Findings Are False
John P. A. Ioannidis
PLoS Med. 2005 Aug; 2(8): e124.
Published online 2005 Aug 30. doi: 10.1371/journal.pmed.0020124
PMID: 16060722

PMCID: PMC1182327 (Free Full Text from PubMed Central)

The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance.



[6] Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices
Vinay Prasad and John PA Ioannidis
Implement Sci. 2014; 9: 1.
Published online 2014 Jan 8. doi: 10.1186/1748-5908-9-1
PMID: 24398253

PMCID: PMC3892018 (Free Full Text from PubMed Central)

Abandoning ineffective medical practices and mitigating the risks of untested practices are important for improving patient health and containing healthcare costs. Historically, this process has relied on the evidence base, societal values, cultural tensions, and political sway, but not necessarily in that order. We propose a conceptual framework to guide and prioritize this process, shifting emphasis toward the principles of evidence-based medicine, acknowledging that evidence may still be misinterpreted or distorted by recalcitrant proponents of entrenched practices and other biases.


[7] Observational studies often make clinical practice recommendations: an empirical evaluation of authors’ attitudes
Vinay Prasad 1, Joel Jorgenson, John P A Ioannidis, Adam Cifu
J Clin Epidemiol.
2013 Apr;66(4):361-366.e4.
PMID: 23384591   DOI: 10.1016/j.jclinepi.2012.11.005

It is common to see new studies contradict previous adopted standards of care [25,26]. Even the results of highly cited studies can be refuted [7], and the replication rate tends to be low for claims made from observational designs [7]. We have previously noted that the most common correlate for reversal of standards of care was the original adoption of a practice based on nonrandomized evidence alone [27]. The studies examined here offer many recommendations that may be precarious or erroneous. If adopted, such practices may need to be reversed in the future after having been detrimental to health, health finances, and the reputation of medical science.



[8] Contradicted and initially stronger effects in highly cited clinical research
John P A Ioannidis
JAMA. 2005 Jul 13;294(2):218-28. doi: 10.1001/jama.294.2.218.
PMID: 16014596   DOI: 10.1001/jama.294.2.218

Free Full Text from JAMA

Of the 45 eligible highly cited studies with efficacy claims (Table 2), 7 (16%) were contradicted by subsequent research, and another 7 (16%) were found to have initially stronger effects. In all these 14 cases (BOX 1), subsequent studies were either larger or better controlled (randomized vs a nonrandomized original study). The findings of 20 highly cited articles (44%) were replicated (also with a larger sample size in subsequent research compared with the original highly cited study) and 11 (24%) had remained largely unchallenged.58-78



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Happy Darwin and Lincoln Day 2020


Happy Lincoln-Darwin Day!
 
Today is the birthday of two people considered enemies by the American slavery belt – Charles Darwin and Abraham Lincoln. The slavery belt was so afraid of Lincoln that most of the slave states seceded before Lincoln took office as president.

Charles Darwin wrote a book that exposed the slavery of human beings as immoral. The slaves were just as human as every slave owner. Bible quotations in defense of slavery were regularly provided by slave owners to justify their immorality, but it was not working as well as it used to. To be fair, many of the Founding Fathers opposed slavery, but this was a compromise that will always stain the Constitution. There was even an agreement in the Constitution to allow the importation of slaves at least until 1808.
 

The Migration or Importation of such Persons as any of the States now existing shall think proper to admit, shall not be prohibited by the Congress prior to the Year one thousand eight hundred and eight, but a tax or duty may be imposed on such Importation, not exceeding ten dollars for each Person.[1]

 

There was enough opposition to the importation of slaves that a law prohibiting importation went into effect the first day possible – January 1, 1808.

Opponents of Lincoln continue to make excuses for the treason of the slave states that seceded and made war on the United States of America.

Opponents of Darwin continue to make excuses for rejection of biology, even though genetics and evolution are essential for the understanding of biology. Denial of science has become a tenet of Creationist sects.

Currently the most popular method of denying science is the one made notorious by the exposure of private documents of the cigarette industry. Create the appearance of scientific doubt and scientific controversy, even though the only doubt and controversy is about minor details, rather than the broad conclusions.
 

The most important type of story is that which casts doubt in the cause and effect theory of disease and smoking. Eye-grabbing headlines should strongly call out the point[2]

 

 

Doubt is our product next hit since it is the best means of competing with the “body of fact” that exists in the mind of the general public. It is also the means of establishing a controversy. Within the business we recognize that a controversy exists. However, with the general public the consensus is that cigarettes are in some way harmful to the health. If we are successful in establishing a controversy at the public level, then there is an opportunity to put across the real facts about smoking and health. previous hit Doubt is also the limit of our ” product.” Unfortunately, we cannot take a position directly opposing the anti-cigarette forces and say that cigarettes are a contributor to good health. No information that we have supports such a claim .

Truth is our message because of its power to withstand a conflict and sustain a controversy. If in our pro-cigarette efforts we stick to well documented fact , we can dominate a controversy and operate with the confidence of justifiable self-interest [italic emphasis added]. {2111.01, pp. 4, 5}[3]

 

The point was to create the appearance of honesty, without the substance. This method is used by a lot of other science denialists – anti-vaxers, climate change deniers (both those who deny that climate change is real and those who claim that human activity is not responsible for the dramatic acceleration of global warming), flat earthers, alternative medicine promoters, anti-GMO activists, anti-abortion activists, anti-equality activists, geocentrists, et cetera.

Reality is their enemy.

Reality will always be their enemy.

Footnotes:

[1] Article 1 Section 9
U.S. Constitution
Link to Article 1 Section 9 at constitution.net

[2] Tobacco Explained – The truth about the tobacco industry …in its own words
World Health Organization
Page 11/79 on the pdf counter, but marked as page 7 on the page
Free Full Text in PDF format from WHO
 

Carl Thompson from Hill and Knowlton writes a letter on the best angles for the
industry magazine, Tobacco and Health Research:
“The most important type of story is that which casts
doubt in the cause and effect theory of disease and
smoking. Eye-grabbing headlines were needed and
“should strongly call out the point – Controversy! Contradiction! Other Factors! Unknowns!” 31 (Hill and
Knowlton, 1968)

 

[3] Using Cigarette Ads to Counter Health Information
The Cigarette Papers
Chapter 5 Public Relations in the “Safe” Cigarette Era
Resisting Government Regulation: Advertising Campaigns
Pages 190-191
University of California Press
Link to book with search for “Doubt is our product”

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How Effective Is Epinephrine for Improving Survival Among Patients in Cardiac Arrest?

   

There have been two studies comparing epinephrine with placebo to treat out of hospital cardiac arrest. The Jacobs study was stopped early, because of interference by those who do not want to know if their medicine actually works.[1] The purpose of research is to determine, as objectively as possible, if a treatment is better than placebo nothing.  

Click on the image to make it larger.  

Even the small sample size shows a impressive p values of <0.001 for both ROSC (Return Of Spontaneous Circulation) and being admitted to the hospital. Unfortunately, that does not lead to outcomes that are better than placebo.

The Perkins study (PARAMEDIC2) did not find a significant difference between adrenaline (epinephrine in non-Commonwealth countries) and placebo.[2] The Jacobs study also did not find a difference, but the numbers were small, due to the interference by the less than knowledgeable. Following the Jacobs study, some intervention proponents have suggested that the problem is not a lack of evidence of benefit, but need to look at the evidence from the right perspective. The inadequate evidence is not “inadequate”, but really just misunderstood. All we need to do is use a method of analysis that compensates for the tiny sample size. A Bayesian approach will produce the positive outcome that is not justified by so few patients.[3]

What happens when the numbers are combined, so that the sample size is large enough to eliminate the need for statistical chicanery to come up with something positive?

The outcomes do not improve.  

Neither standard dose adrenaline, high-dose adrenaline,vasopressin nor a combination of adrenaline and vasopressin improved survival with a favourable neurological outcome.[4]
 

If the Bayesian approach were appropriate, then the much larger sample size would have provided more than enough patients to confirm the optimism of the epinephrine advocates. The result is still not statistically significant. Maybe a much, much larger study will show a statistically significant, but tiny, improvement in outcomes with epinephrine, but don’t hold your breath for that. It took half a century to produce the first study, then seven more years for the second. With the cost of research and the problems coordinating such a large study, it is more likely that the guidelines will continue to recommend spending a lot of time and money giving a drug that diverts attention from the interventions that do improve outcomes.

There is still no evidence that adrenaline provides better outcomes than placebo in human cardiac arrest patients.

  –  

Footnotes:

  –  

[1] Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial Jacobs IG, Finn JC, Jelinek GA, Oxer HF, Thompson PL. Resuscitation. 2011 Sep;82(9):1138-43. doi: 10.1016/j.resuscitation.2011.06.029. Epub 2011 Jul 2. PMID: 21745533

Free Full Text PDF Download from semanticscholar.org  

This study was designed as a multicentre trial involving five ambulance services in Australia and New Zealand and was accordingly powered to detect clinically important treatment effects. Despite having obtained approvals for the study from Institutional Ethics Committees, Crown Law and Guardianship Boards, the concerns of being involved in a trial in which the unproven “standard of care” was being withheld prevented four of the five ambulance services from participating.

In addition adverse press reports questioning the ethics of conducting this trial, which subsequently led to the involvement of politicians, further heightened these concerns. Despite the clearly demonstrated existence of clinical equipoise for adrenaline in cardiac arrest it remained impossible to change the decision not to participate.

  –  

[2] A Randomized Trial of Epinephrine in Out-of-Hospital Cardiac Arrest. Perkins GD, Ji C, Deakin CD, Quinn T, Nolan JP, Scomparin C, Regan S, Long J, Slowther A, Pocock H, Black JJM, Moore F, Fothergill RT, Rees N, O’Shea L, Docherty M, Gunson I, Han K, Charlton K, Finn J, Petrou S, Stallard N, Gates S, Lall R; PARAMEDIC2 Collaborators. N Engl J Med. 2018 Aug 23;379(8):711-721. doi: 10.1056/NEJMoa1806842. Epub 2018 Jul 18. PMID: 30021076

Free Full Text from N Engl J Med.

  –  

[3] Regarding “Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial”. Youngquist ST, Niemann JT. Resuscitation. 2012 Apr;83(4):e105; author reply e107. doi: 10.1016/j.resuscitation.2011.09.035. Epub 2012 Jan 18. No abstract available. PMID: 22266068

Free Full Text from Resuscitation.

  –  

[4] Adrenaline and vasopressin for cardiac arrest. Finn J, Jacobs I, Williams TA, Gates S, Perkins GD. Cochrane Database Syst Rev. 2019 Jan 17;1:CD003179. doi: 10.1002/14651858.CD003179.pub2. PMID: 30653257    

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Vaccines are probably the safest and most effective medical intervention available, so why do anti-vaxers lie about them

 

Why does anyone lie?

Anti-vaxers lie for the same reason as other people – for personal benefit.

Many anti-vaxers claim that there is an international conspiracy of doctors and researchers, as if all of the doctors and researchers, or even the pediatric doctors and researchers, in the world could agree on much of anything. When you realize how ridiculously large this conspiracy would be, how much a doctor or researcher would gain from providing valid information to expose such a conspiracy, and how aggressively law enforcement would punish those behind such a conspiracy, you understand the use of ridiculous is appropriate as a description of the conspiracy theory.

This is just another example of some people thinking they know more than everyone else, based on a lack of understanding. This feeds the over-inflated egos of anti-vaxers.

The smallpox vaccine has saved hundreds of millions of lives. Anti-vaxers opposed the smallpox vaccine and delayed the eradication of smallpox. Anti-vaxers helped smallpox kill people..

Our children are no longer vaccinated against smallpox, because smallpox has been wiped out by vaccines. Millions of children’s lives, and adult lives, are saved every year by the smallpox vaccine, without even giving it to children, because enough people rejected the lies of anti-vaxers.

Vaccines continue to save millions of lives every year, in spite of opposition by anti-vaxers.

There is plenty of research showing that vaccines are effective and safe, but to give the single clearest example of the benefit of vaccines, look at the following paper from JAMA. The Journal of the American Medical Association is one of the most respected medical publications in the world. Use any search engine to find a list of the most respected medical journals and you will find JAMA near the top.

Look at the decrease in the rates of illness and the rates of death for each vaccine-preventable illness after the introduction of the vaccine for that illness. Click on the image for a larger, easier to read version.
 


 

Table 1. Historical Comparison of Morbidity and Mortality for Vaccine-Preventable Diseases With Vaccines Licensed or Recommended Before 1980: Diphtheria, Measles, Mumps, Pertussis, Poliomyelitis, Rubella, Smallpox, Tetanusa [1]

 

This information has been simplified for those not comfortable with scientific research (I do not know the source of the image, it was not part of the paper in JAMA):
 


 

As you can see, these diseases are almost never a problem in America, where vaccination rates are still pretty high, although anti-vaxers are causing more and more outbreaks of diseases we had not seen in decades.

Some anti-vaxers will claim that the vaccines didn’t get rid of these diseases. These anti-vaxers claim that improved sanitation, improved hygiene, and improved diet got rid of these diseases. While these improvements are helpful, here is why that is just another anti-vax lie.

We have outbreaks of vaccine-preventable illnesses in America, when the rate of vaccination drops, even though sanitation, hygiene, and diet did not deteriorate. Yes, many of our diets are getting worse, but that is not what is causing outbreaks of whooping cough, measles, and other vaccine-preventable illnesses.

The rates of illness and death only have a dramatic change for each of the vaccine-preventable illnesses after the introduction of each vaccine. If sanitation, hygiene, and diet were the reasons, the illnesses would all start to go away at the same time, although not necessarily at the same rate. If that were the case, the decreases in these diseases could easily be shown to be due to improvements in sanitation, hygiene, and diet, but that is not the case.

Anti-vaxers cannot explain that, but anti-vaxers are not reasonable.
 

Why has the polio vaccine been so effective in India, when India has widespread problems with sanitation, hygiene, and diet?

Here is what the authors wrote:
 

India, a vastly diverse country with a 27 million birth cohort, undertook the largest vaccination drive against WPV (Wild Polio Virus) in the world. With high population density, poor civic infrastructure, poor sanitation, an almost nonexistent public health system, rampant malnutrition and diarrhea, difficult-to-reach locales, high population mobility, and extremely high force of WPV transmission in few states,3 the interruption of WPV transmission was extremely difficult and demanding. The interplay of these challenging factors provided a perfect milieu for the WPV to circulate, and the prospect of achieving zero-polio status seemed insurmountable.[2]

 

India completed a full 5 years as a “polio-free nation” on January 13, 2016.1 It was a remarkable feat considering the odds against achieving this status. [2]

Anti-vaxers will make excuses, but this clearly exposes the anti-vax lie that disease elimination being due to improved sanitation, hygiene, and diet, rather than due to vaccines.
 

The reason smallpox vaccine is no longer given to children, is the worldwide eradication of smallpox by vaccination.

Anti-vaers delayed the worldwide eradication of smallpox.

Anti-vaxers have prevented the worldwide eradication of polio.

Anti-vaxers continue to try to protect polio from eradication.

Children would no longer need polio vaccination, if it weren’t for anti-vaxers.

If you don’t like giving the polio vaccine to your child, blame the anti-vaxers.

Footnotes:

[1] Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States.
Roush SW, Murphy TV; Vaccine-Preventable Disease Table Working Group.
JAMA. 2007 Nov 14;298(18):2155-63.
PMID: 18000199

You can also read the full text of the article for free at JAMA at the link below, if you want to understand more of the details that the anti-vaxers don’t want you to understand.

Historical Comparisons of Morbidity and Mortality for Vaccine-Preventable Diseases in the United States

[2] Polio Eradication in India: The Lessons Learned.
Thacker N, Vashishtha VM, Thacker D.
Pediatrics. 2016 Oct;138(4). pii: e20160461. Epub 2016 Sep 2. Review. No abstract available.
PMID: 27590898

You can also read the full text of the article for free at Pediatrics at the link below, if you want to understand more of the details that the anti-vaxers don’t want you to understand. Pediatrics is one of the most respected pediatric medical publications in the world. Use any search engine to find what pediatric medical journals are the most respected and you will find Pediatrics near the top.

Polio Eradication in India: The Lessons Learned

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Anti-Vaccine Means Pro-Corruption

 

Can you be opposed to vaccines and not be supporting corruption? What does it mean to oppose vaccines?

Vaccines are probably the safest and most effective medical intervention available. Anti-vaxers oppose that.

Vaccines save millions of lives every year. Anti-vaxers oppose that.

If you disagree, provide valid evidence that anything else is as safe as vaccines and provide valid evidence that anything else is as effective as vaccines. There is the small possibility that I am wrong and that vaccines are only second, or maybe even third, among the safest and most effective medical interventions available.

But aren’t the anti-vaxers trying to protect children from unnecessary risk?

That is one of many anti-vaccine claims, but it is just another anti-vax lie.

Look at these heroes of the anti-vaccine propaganda industry. Mark and David Geier.

David Geier pretends to be a doctor, even though he never has been a doctor, or even been enrolled in a medical school.
 

As explained above, the Board concludes that David Geier practiced medicine in Maryland without being licensed by the Board to practice in violation of section 14-601 of the Health Occupations Article.[1]

 

Mark Geier did become a doctor, but the corruption of the anti-vax propaganda and treatment business led him to violate his responsibility to protect his patients. If you see Mark Geier working as a doctor, call the police.
 

Since 2011, Geier’s medical license has been suspended or revoked in every state in which he was licensed over concerns about his autism treatments and his misrepresentation of his credentials to the Maryland Board of Health, where he falsely claimed to be a board-certified geneticist and epidemiologist.[4] [2]

 

What is so bad about the Geiers and why do anti-vaxers continue to worship the Geiers?

Mark and David Geier castrate children with a chemical that has been approved for some medical uses, but definitely not to treat autism. The chemical has never been shown to be safe or even slightly effective for that purpose. If you think that autism is the worst thing ever – worse than smallpox, measles, polio, pertussis, et cetera, you may think that it is morally acceptable to torture children and to have faith in these quacks.
 


 

The fake doctor (David) is on the left and the revoked license doctor (Mark) is on the right.

But isn’t it an exaggeration to call this chemical castration.
 

Speaking about one teen he put on the drug, Mark Geier said: “I wasn’t worried about whether he would have children when he is 25 years old. If you want to call it a nasty name, call it chemical castration. If you want to call it something nice, say you are lowering testosterone.”[3]

 

For those who claim that this would be a short-term treatment, and the side effects would be minimized, that’s not the way quacks work – especially with paying customers. These are not reasonable people. Quacks will be expected to keep giving the magic treatment, possibly increasing the dose several times, until that treatment works, because they think that they know believe that it works. Reasonable people would be expected to stop never start this unapproved and dangerous treatment to begin with. Since the treatment does not work, and is expected to make the patients’ conditions worse, these people would not be expected to stop. As with other alternative medicine, treatment failures are blamed on the patient, or on the family. Quacks do not take responsibility for the incompetence of using chemicals that are dangerous and ineffective.

But what if it really does work?

Almost every proposed treatment, regardless of what it is, will be found to be more harmful than beneficial. Most are discarded long before they get to the point of being tested on actual humans. Poisoning patients, based on What if it works? is dangerous, unethical, and irresponsible.

If you have an autistic child, do not let the Geiers chemically castrate your child for fun and profit.

How do the same anti-vaxers, who claim that they are protecting their children from what is probably the safest and most effective medical intervention available, support this dangerous, unethical, and irresponsible treatment?

That is the way anti-vaxers think. Anti-vccine claims are arrogant rejections of competence, science, and reality. Protect your children from anti-vaxers.

Footnotes:

[1] In the matter of David A. Geier before the Maryland State Board of Physicians
Case Nos. 2008-0022 & 2009-0318
Maryland Department of Health
Final Decision and Order in PDF format.

[2] Mark Geier
Wikipedia
Article

[3] ‘Miracle drug’ called junk science
Trine Tsouderos
Tribune reporter
May 21, 2009
Article

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Anti-Vax Doctors Lack Competence and Ethics

 
 

Effective July 27, 2018, the latest anti-vax doctor to have his license revoked will be Dr. Bob Sears. Yes, he promotes his image as Dr. Bob.

Who are the dangerous doctors Bob Sears will be joining?

Andrew Wakefield‘s fraudulent research, unnecessarily painful research on children, lack of ethical approval for research, and other corruption, convinced the British General Medical Council to revoke his license. Wakefield was also trying to sell a vaccine of his own, to compete with the MMR (polyvalent Measles, Mumps and Rubella) vaccine. Wakefield’s attempts to discredit the MMR vaccine would have helped him to sell his own competing vaccine.
 

the lawyers responsible for the MMR lawsuit had paid Wakefield personally more than £400,000, which he had not previously disclosed.[67] [1]

 

Andrew Wakefield claims that he is not a fraud and sues a lot of people.

All of the cases have been thrown out by the courts or have been withdrawn by Wakefield.[2]

Do those who claim to be trying to protect their children, by avoiding vaccines, based on a trust of this fraudulent doctor, know what Wakefield has done?

The kiddie castrators – David Geier and Mark Geier.

David Geier was never a doctor, but has been caught faking it.[3] In the make believe world of anti-vaxers, why let reality get in the way of pretending to have credibility?

Mark Geier was a doctor, but had his license revoked in every state where he had a license (Maryland, Washington, Virginia, California, Missouri, Illinois, and Hawaii). Why do the Geiers castrate children? Chemical castration is an approved treatment for some rare conditions. Mastectomy is an approved treatment for some breast cancers, but that does not mean that it is at all ethical, or competent, to recommend mastectomy as treatment for other medical conditions. The Geiers claim to believe that castration cures autism. There is no valid evidence to support their hunch.

Consider this. You have an autistic child and someone tells you there is a cure. The person says that they know their expensive chemicals work. The person may even say, I’ve seen it work.[4] All you have to do is give permission for this doctor (before his license was revoked), and his son the fake doctor, to use chemicals to castrate your child.

Do you ask for evidence?

Their is no valid evidence. You just have to trust the castrators and their excuses for the absence of evidence.

The “evidence” has been retracted, because the research is junk science. All human research has to be approved by an independent IRB (Institutional Review Board) to make sure that there are not any conflicts of interest or unnecessary risks to the children participating in the research. The members of the independent IRB were the Geiers, the Geier’s employees, and the Geier’s lawyer. That is not independent.

If chemical castration doesn’t work, the Geiers can sell you other expensive and dangerous treatments that do not work, such as chelation. Chelation is the use of chemicals to remove heavy metals from the body, based on the assumption that mercury causes autism. Chelation is harmful, so it is only indicated, when there is a good reason to believe the benefit will be greater than the harm. There is no valid evidence to support this hunch of the Geiers.

The motto of the company run by the Geiers is First do no harm. Are they completely unaware of the harm they cause, or so dishonest that they tell the boldest lies? Does it matter why they harm children?

What did Bob Sears do to get his license revoked? He claimed to assess patients, but did not keep records of what he claimed to do. His incompetence/negligence endangered patients.[5] ,[6]

For example, a mother frequently brought J.G., a 2 year old, to see Dr. Bob. One visit was for a head ache a couple of weeks after the child’s father hit the child on the head with a hammer. The only apparent concern of the mother and Dr. Bob was to prevent the child from receiving vaccines. There is no record of any neurological assessment, or referral to a competent doctor for a neurological assessment.

J.G. had visited Dr. Bob the previous month for constipation. Assessment and treatment plans were documented. Constipation can be very serious, but so can hitting a child on the head with a hammer. The reason for the difference in approaches was determined to be gross negligence. Another visit, following apparent resolution of otitis media following treatment with Omnicef (cefdinir), there was a diagnosis of a sudden onset of flu, with a prescription for Tamiflu (oseltamivir), so there is no apparent hesitation to use ineffective, or minimally effective, treatments. Is J.G.’s last name Munchausen, or is he just unlucky in his choice of parents?

Bob Sears does not appear to be hesitant to prescribe drugs based on hunches, but he does appear to recognize that being anti-vax can be very profitable. Sears has written 4 books, but still fails to document assessments.

Bob Sears will have to be monitored by another physician for 35 months, following this revocation, to be able to get his license reinstated. He must follow all laws, not be negligent, and not deviate from the standard of medical care. He cannot just take the 3 years off and write books, because he has to be monitored while working to get his license back.

It looks like Bob Sears will be vaccinating children, just as real doctors do.

Vaccines save millions of lives every year.

Vaccines are probably the safest and most effective medical intervention we have, and anti-vaxers hate that.

If some of us do not see the need for vaccines, it is because of the success of vaccines. Vaccines are an important part of the reason that the average life expectancy has doubled in a little over 100 years.

For a great review of the effect of vaccines on vaccine-preventable illnesses, there is a study in JAMA (Journal of the American Medical Association), which shows how the rate of each illness, and deaths from each illness, declined after the introduction of each vaccine. There are anti-vaxers who claim that it wasn’t the vaccines, but sanitation that stopped these illnesses. Don’t fall for that.[7]

Sanitation is important at preventing the spread of illnesses, but sanitation does not wait for each different vaccine to be introduced for each different vaccine-preventable illness to change the illness and fatality rates.

Look at the evidence.

Historical comparisons of morbidity and mortality for vaccine-preventable diseases in the United States.
Roush SW, Murphy TV; Vaccine-Preventable Disease Table Working Group.
JAMA. 2007 Nov 14;298(18):2155-63.
PMID: 18000199

Free Full Text Article from JAMA.

Footnotes:

[1] Aftermath of initial controversy
Andrew Wakefield
Wikipedia
Article

The referenced article by Brian Deer is:

Huge sums paid to Andrew Wakefield
The Sunday Times
December 31 2006
Brian Deer
Article

Andrew Wakefield has repeatedly sued Brian Deer and lost or run away every time.

[2] Deer counter-response
Andrew Wakefield
Wikipedia
Article

[3] Medical licenses revoked
Mark Geier
Wikipedia
Article
 

In 2011, his son David Geier was charged by the Maryland State Board of Physicians with practicing as if a licensed physician when he only has a Bachelor of Arts degree in biology,[42] and was fined $10,000 in July 2012.[40]

 

Charges by the Maryland Medical Board
In the Matter of David A. Geier before the Maryland State Board of Physicians
Practicing without a license
PDF document of charges
 

The Respondent is not and never has been licensed to practice medicine or any other health profession in the State of Maryland or any other State.

 

[4] I’ve Seen It Work and Other Lies
Tue, 21 Jun 2011
Rogue Medic
Article

[5] Antivaccine pediatrician Dr. Bob Sears finally faces discipline from the Medical Board of California
Respectful Insolence
Orac
June 29, 2018
Article

[6] Stipulated Settlement and Disciplinary Order
Decision of the Medical Board of California
Department of Consumer Affairs
State of California
Case No. 800-2015-012268
OAH No. 2017100889
PDF of Decision

[7] “Vaccines didn’t save us” (a.k.a. “vaccines don’t work”): Intellectual dishonesty at its most naked
Science-Based Medicine
David Gorski
March 29, 2010
Article

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Have a Slow, Quiet Friday the Thirteenth

Also to be posted on ResearchBlogging.org when they relaunch the site.
 

 

Superstitious appears to be common among medical people, so this may be seen as offensive. If you doubt me, comment that it is slow or quiet and see how many respond negatively, while they do not receive any criticism for their superstition-based complaints. Rather, people will make excuses for coddling the superstitions of those who are entrusted with the lives of patients.

The evidence does not support their superstitions.

One study did appear to show that women die in motor vehicle collisions more often on Friday the 13th, but that appears to be due to a lack of understanding of statistics by many who cite the article.
 

An additional factor is anxiolytic medication, used by significantly more women than men in Finland (7), which has been reported to reduce attention span and worsen driving performance (8). . . . Why this phenomenon exists in women but not in men remains unknown, but perhaps the twice-as-high prevalence of neurotic disorders and anxiety symptoms in women (7) makes them more susceptible to superstition and worsening of driving performance.[1]

 

The author suspects that those people with conditions that could be diagnosed as neuroses or anxiety disorders may be disproportionately affected by superstition.

In other words, superstition is not an external force affecting you. You are doing it to yourself.

The sample size was national, but still small, and was not able to adjust for many possible confounding variables, so the study would need to be replicated using a much larger data base to be useful.

In other superstition news – the next apocalypse, in a long line of predicted apocalypses, is going to be this Sunday – the 15 of October, 2017, according to David Meade. Meade twice previously predicted that a magical planet would hit the Earth and kill us all. This time he claims that his calculations are accurate, because that was the problem with his previous calculations – inaccuracy, not that they were a superstition deserving of derision.

If you are superstitious, and feel that your neuroses/anxieties will cause you to harm others, or yourself, you may want to stay home today and Sunday – perhaps even until you are capable of grasping reality.

Of course, we would never base treatment on superstition in medicine.

Amiodarone is the go to antiarrhythmic drug for cardiac arrest and ventricular tachycardia, but there are much safer much more effective drugs available. We have our own prophets misrepresenting research results to make it seem that using amiodarone for these is a good idea. The research says these preachers are wrong. The next guidelines will probably promote the superstition and reject the science.[2],[3]

Ventilation during cardiac arrest has been shown to be a good idea only for patients who arrested for respiratory reasons. We do a great job of identifying these patients. We have our own prophets misrepresenting research results to make it seem that providing ventilations for these is a good idea. The research says these preachers are wrong. The next guidelines will probably promote the superstition and reject the science.[4]

Medicine is full of superstition and superstitious people.

Why?

Too many of us believe the lie that, I’ve seen it work.

I have also written about the superstition of Friday the 13th here –

Acute coronary syndrome on Friday the 13th: a case for re-organising services? – Fri, 13 Jan 2017

The Magical Nonsense of Friday the 13th – Fri, 13 May 2016

Happy Friday the 13th – New and Improved with Space Debris – Fri, 13 Nov 2015

Friday the 13th and full-moon – the ‘worst case scenario’ or only superstition? – Fri, 13 Jun 2014

Blue Moon 2012 – Except parts of Oceanea – Fri, 31 Aug 2012

2009’s Top Threat To Science In Medicine – Fri, 01 Jan 2010

T G I Friday the 13th – Fri, 13 Nov 2009

Happy Equinox! – Thu, 20 Mar 2008

Footnotes:

[1] Traffic deaths and superstition on Friday the 13th.
Näyhä S.
Am J Psychiatry. 2002 Dec;159(12):2110-1.
PMID: 12450968

Free Full Text from Am J Psychiatry.

[2] The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
Wed, 17 Aug 2016
Rogue Medic
Article

There are a dozen links to the research in the footnotes to that article. There are also links to other articles on the failure of amiodarone to live up to its hype.

[3] Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’
Tue, 12 Apr 2016
Rogue Medic
Article

[4] Cardiac Arrest Management is an EMT-Basic Skill – The Hands Only Evidence
Fri, 09 Dec 2011
Rogue Medic
Article

.