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

- Rogue Medic

What’s the Good News on Hydroxychloroquine?

Hydroxychloroquine is a darling of the media and of politicians, but what about the evidence? Well, the evidence on the use of hydroxychloroquine to treat humans with COVID-19 (COronaVIrus Disease identified in 2019) is either negative (hydroxychloroquine is worse than homeopathy, acupuncture, naturopathy, prayer, . . . ) or the evidence is neutral (hydroxychloroquine is just as useless as homeopathy, acupuncture, naturopathy, prayer, . . . ).


But what is the good news?


The good news is that all of the research on hydroxychloroquine is of low quality or of very low quality. This is exactly the kind of evidence that frauds use to sell their fly by night panaceas.


The “best” news for the frauds is that one study showing harm from hydroxychloroquine has been retracted by most of the authors, due to problems with the data.[1],[2] The researchers contracted out the data acquisition and analysis to Surgisphere Corporation, a private company that appears to have promised to be able to deliver more than it can deliver.


If the negative paper has been retracted, why am I calling the promoters of hydroxychloroquine the frauds?


I am not referring to any of the researchers as frauds, not even the ones from the company that provided the retracted information. The frauds are the people promoting hydroxychloroquine without any evidence that hydroxychloroquine is safe or effective to treat COVID-19 in our species. These people are recklessly and irresponsibly endangering people for their own apparently political reasons.


We still do not have any valid evidence that hydroxychloroquine is safe to use in any humans to treat COVID-19.


We still do not have any valid evidence that hydroxychloroquine is effective at improving any outcomes for any humans with COVID-19.


Experimentation on humans should be limited to well controlled research studies.


The WHO (World Health Organization) appropriately, and only temporarily, paused research on hydroxychloroquine to re-examine the safety data available. The enrollment of patients in the WHO research has resumed.[3]


For those who claim that this retraction is evidence that science doesn’t work – It is amusing to see you trying to cite evidence to support your rejection of evidence, every time you do it. May you never tire of demonstrating the validity of the Dunning-Kruger effect.


This is like using a stopped clock to tell you the time. The stopped clock does not provide any useful information about the actual time, but it does provide useful information about the person claiming it provides useful information about the time.



This was pre-print – not yet peer reviewed, which was retracted by most of the authors, because of questions raised about the data. It may turn out that the outcomes for patients were better than represented in the paper. It may turn out that the outcomes for patients were the same as than represented in the paper. It may turn out that the outcomes for patients were worse than represented in the paper. We won’t know until the full information is independently analyzed, which might not happen. The failure to provide access for independent analysis was the reason for the retraction.


Late addition (6/08/2020 at 15:08): Dr. Steven Novella has a more detailed description of this at Neurologica, written on 6/08/2020 after I posted this on 6/06/2020:


The Surgisphere Fiasco



Footnotes:


[1] Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.
Mehra MR, Desai SS, Ruschitzka F, Patel AN.
Lancet. 2020 May 22:S0140-6736(20)31180-6. doi: 10.1016/S0140-6736(20)31180-6. Online ahead of print.
PMID: 32450107


Free Full Text from PubMed Central.


[2] Retraction—Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis
Mandeep R Mehra, Frank Ruschitzka, Amit N Patel
Published:June 05, 2020
DOI:https://doi.org/10.1016/S0140-6736(20)31324-6


[3] “Solidarity” clinical trial for COVID-19 treatments
WHO (World Health Organization)
Information page.


Update on hydroxychloroquine


Originally posted 27 May 2020, updated 4 June 2020


Having met on 23 May 2020, the Executive Group of the Solidarity Trial decided to implement a temporary pause of the hydroxychloroquine arm of the trial, because of concerns raised about the safety of the drug. This decision was taken as a precaution while the safety data were reviewed by the Data Safety and Monitoring Committee of the Solidarity Trial.


On 3 June 2020, WHO’s Director-General announced that on the basis of the available mortality data, the members of the committee have recommended that there are no reasons to modify the trial protocol.


The Executive Group received this recommendation and endorsed the continuation of all arms of the Solidarity Trial, including hydroxychloroquine.


The Data Safety and Monitoring Committee will continue to closely monitor the safety of all therapeutics being tested in the Solidarity Trial.



.

Hydroxychloroquine – The More You Know, The Worse It Looks



Do you want to use a drug that was never based on any good evidence, but only a hunch? Try hydroxychloroquine. The president says, What have you got to lose?


Kitchen sink medicine is a remnant of the Dark Ages, but it has not been eliminated from medicine. It is the argument from ignorance. If you can’t prove that the treatment is harmful, the treatment is wonderful. If you can prove the treatment is harmful, you are part of a conspiracy.


This is further evidence that hydroxychloroquine is harmful. The higher the quality of the evidence about hydroxychloroquine, the worse hydroxychloroquine looks.


Today, Lancet published this study comparing almost 15,000 patients receiving several different experimental treatments with about 80,000 patients not receiving any of the experimental treatments. This should convince reasonable people that there is no justification for treating patients with hydroxychloroquine outside of a well controlled randomized trial.


The comments on articles about the study are full of the usual anti-science, anti-vax, alternative medicine propaganda. Their religion has failed, but they keep preaching.


After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223–1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368–1·531), chloroquine (16·4%; 1·365, 1·218–1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273–1·469) were each independently associated with an increased risk of in-hospital mortality.[1]


The evidence shows that you are twice as likely to die if you receive hydroxychloroquine.


Don’t listen to anti-science, anti-vax, anti-medicine preachers, because they are not interested in your health.


What have you got to lose?


What are you treating, you politics/religion or your health?


If your goal is to treat your religion, go ahead and use the magic elixir and maybe you will not be harmed by it.


If your goal is to treat your health, avoid magic claims about treatments, regardless of the treatment. Use treatments that work in the real world.


What have you got to lose?


You are twice as likely to lose your life. Among survivors, the significant adverse effect rate was much higher in the hydroxychloroquine groups. This is the highest quality research so far and there is no good news for the hydroxychloroquine.


Read the full paper and think for yourself. Don’t listen to those making excuses to promote their agenda. Your health has never been important to those who reject science.


It is unfortunate that we do not have some treatment that works well, but that is not a good reason to bet your life on bad medicine. More people survive with better health with conventional treatment.



Footnotes:


[1] Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis
Prof Mandeep R Mehra, MD, Sapan S Desai, MD, Prof Frank Ruschitzka, MD, Amit N Patel, MD
Lancet. Published:May 22, 2020
DOI:https://doi.org/10.1016/S0140-6736(20)31180-6


Free Full Text from Lancet.


.

Dr. David Price on How to Stay Healthy, While Treating COVID-19 Patients

Here is a quote from 2007, written about the response to the 1918 influenza pandemic.

 

Influenza pandemics have occurred regularly every 30 to 40 years since the 16th century. Today, influenza experts consider the possibility of another influenza pandemic, not in terms of if but when. Due to the high likelihood of an influenza pandemic, planning is underway in many U.S. states and other countries. We reviewed the responses of two neighboring Minnesota cities during the 1918–1919 pandemic to gain insight that might inform planning efforts today.[1]

 

We have chosen to forget what we had already learned. We can expect fewer deaths, this time, but this is a result of the arrogance and complacency that is our willful ignorance.

 

We work with patients who may not know that they have COVID-19 (novel COronaVIrus Disease identified in 2019), but we still have to treat them, just as we do for every other infectious disease. The same is true for patients who have tested positive for COVID-19. We are expected to take care of them, protect our other patients from transmission by us, and protect ourselves from infection.

 

Here is the advice, based on the best available evidence, from Dr. David Price of Weill Cornell Medical Center in New York City, currently the hottest spot of COVID-19 transmission in the world, but that will change. Dr. Price is a pulmonologist, treating COVID-19 patients full time, but he is not worried about becoming sick, because he uses evidence-based practices to protect himself. The quality of the video is not great, but the quality of the information is very high.

 

 

 

 

Some of this is not new. As I already stated, we knew this a century ago. We have chosen to forget how to deal with a pandemic.

 

We need to wash our hands.

 

We need to not touch our faces.

 

The most effective use of a mask may be to train yourself to not touch your face. We should have already been good at that, since we are not supposed to touch our faces, when we are wearing gloves, but many of us do touch our faces with gloves. When we have gloves on, the gloves should be considered to be contaminated, and anything everything we touch with our gloves should also be considered to be contaminated.

 

If you think that you need to be seen by a doctor, call first, because it can probably be handled over the phone.

 

If you think that you need to be seen in the emergency department, you probably do not.

 

Wash your hands before you put gloves on

 

Wash your hands after you take gloves off.

 

Clean everything you touch.

 

Wear an N95 mask, face shield, and a gown, when treating COVID-19 patients.

 

Be considerate of others and do not hoard medical supplies. The medical supplies do not do you any good unless you are treating COVID-19 patients and following these rules.

 

We need more accountability for giving bad dangerously incompetent medical advice.

 

President Trump has been promoting a poorly tested treatment as if he has a financial stake in the drug. A couple followed the “medical advice” of President Trump. One died. The other is in the hospital.[2]

 

In Iran, a bunch of people have consumed methanol to cure/protect against COVID-19. hundreds are reported to have died. Methanol ingestion is something that happens with children, who aren’t old enough to read the warnings on the label.[3]

 

Get your medical advice from a physician who understands evidence-based medicine.

 

We, in America, currently are producing too many new infections each day. We need to control our bad (infection-wise) behaviors in order to protect our patients, our neighbors, our families, and our selves. As health care providers, we should be better at this than everyone else. Too many of us are not.

 

 


Financial Times – Coronavirus: free to read
Click on the link for the full page of the latest graphs from Financial Times or click on the image for a larger version of the graph at the time I wrote this.

 

The countries with the most aggressive spread of COVID-19 are the countries that have not aggressively restricted movement among citizens. Anyone, including President Trump, telling you to ignore the social distancing recommendations is endangering the health of everyone. Most of us will probably become infected. Almost all of us will recover, but the rate of recovery drops if everyone becomes sick at the same time, since we do not have enough ventilators to adequately treat such a dramatic increase in very sick patients. The stock market will recover, although not immediately. The same thing happened a century ago, when dealing with the influenza pandemic.

 


This is a chart of what happened to the stock market before, during, and after the 2018 influenza pandemic.[4] Do not take this as trading advice – maybe if you get your medical advice from science deniers, you should trade, based on this. There are many differences between 2018 and now, such as the size, and importance, of other markets. This isn’t the end of the world, unless you don’t follow safe hygiene practices and get yourself infect. Crying about the economy and worshiping in a “traditional” way should not earn any sympathy for Texas Lt. Gov. Dan Patrick[5], First Things writer R.R. Reno, and Cardinal Raymond Burke.[6] Their promotion of immorality is despicable.

 

Social distancing was effective at limiting the spread of the pandemic.[7]

 

Do not expect a vaccine until 2021 or 2022.

 

Do not expect an effective treatment (something that significantly improves outcomes for patients, rather than just improves the sales for the manufacturers) for several months, at the earliest, because the drug President Trump has been promoting is not supported by good evidence. Ironically, HuffPost, which used to be Huffington Post and used to promote the science denialism of Jenny McCarthy, Dr. Oz, Oprah, and plenty of others, has a good article exposing the problems with the paper being cited by President Trump. Let’s hope that the name change is due to a dramatic change in their approach to reality.[8]

 

Footnotes:

[1] Lessons learned from the 1918-1919 influenza pandemic in Minneapolis and St. Paul, Minnesota.
Ott M, Shaw SF, Danila RN, Lynfield R.
Public Health Rep. 2007 Nov-Dec;122(6):803-10. No abstract available.
PMID: 18051673

Free Full Text from PubMed Central® (PMC)

 

[2] Husband and wife poison themselves trying to self-medicate with chloroquine – An Arizona man is dead and his wife is hospitalized after both of them self-medicated with chloroquine.
By Kimberly Hickok – Reference Editor
3 days ago
Live Science
Article

 

[3] Bootleg Liquor and Why You Should Not Drink Methanol
By Live Science
Staff September 19, 2012
Article

 

[4] Market action a century ago suggests worst could be over for stocks, if not for the coronavirus pandemic
Published: March 19, 2020 at 1:50 p.m. ET
By Shawn Langlois
MarketWatch
Article

 

[5] Texas Lt. Gov. Dan Patrick suggests elderly should die to save economy from coronavirus
By Kate Feldman
New York Daily News
March 24, 2020 | 11:46 AM
Article

 

[6] Editorial: May the lesson be indelibly inscribed — we need one another
Mar 24, 2020
by NCR Editorial Staff
National Catholic Reporter
Article

 

[7] Lessons learned from the 1918-1919 influenza pandemic in Minneapolis and St. Paul, Minnesota.
Ott M, Shaw SF, Danila RN, Lynfield R.
Public Health Rep. 2007 Nov-Dec;122(6):803-10. No abstract available.
PMID: 18051673

Free Full Text from PubMed Central® (PMC)

 

 

Influenza pandemics have occurred regularly every 30 to 40 years since the 16th century. Today, influenza experts consider the possibility of another influenza pandemic, not in terms of if but when. Due to the high likelihood of an influenza pandemic, planning is underway in many U.S. states and other countries. We reviewed the responses of two neighboring Minnesota cities during the 1918–1919 pandemic to gain insight that might inform planning efforts today.

 

Many of the components of current pandemic influenza plans were utilized to some degree in Minneapolis and St. Paul during 1918–1919. Coordination between different levels and branches of government, improved communications regarding the spread of influenza, hospital surge capacity, mass dispensing of vaccines, guidelines for infection control, containment measures including case isolation and closures of public places, and disease surveillance were all employed with varying degrees of success. We focus on medical resources, community disease containment measures, public response to community containment, infection control and vaccination, and communications.

 

[8] The Hucksters Pushing A Coronavirus ‘Cure’ With The Help Of Fox News And Elon Musk – Tucker Carlson, Glenn Beck and more have given a giant platform to a sketchy paper touting chloroquine.
03/20/2020 02:05 pm ET Updated Mar 20, 2020
HuffPost
By Nick Robins-Early
Article

.

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    

.

Protecting Systemic Incompetence – Part I

 

We demand the lowest standards, because we are willfully ignorant and we do not want to understand. The surprise is that so many of us survive our devotion to incompetence. The loudest voices tend to dominate the discussions and the loudest voices demand that their excuses for incompetence be accepted. The rest of us don’t oppose incompetence enough.

A nurse was told to give 2 mg Versed (the most common brand of midazolam in the US) for sedation for a scan, intended to give 1 mg Versed, but actually gave an unknown quantity of vecuronium (Norcuron is the most common brand in the US). The patient was observed to be unresponsive and pulseless by the techs in the scan. A code was called. The family learned the details from a newspaper article, not from the hospital.
 

A Tennessee nurse charged with reckless homicide after a medication error killed a patient pleaded not guilty on Wednesday in a Nashville courtroom packed with other nurses who came in scrubs to show their support.[1]

 

The nurse intended to give a medication that should be limited to patients who are monitored (ECG and waveform capnography), because different patients will respond in different ways. This is basic drug administration and deviation from that basic competence may even have been common in this Neuro ICU (Neurological Intensive Care Unit). We demand low standards, because we do not want to understand.

We don’t need to monitor for that, because that almost never happens.

Except these easily preventable errors do happen. And we lie about it. We help to cover it up, because we demand low standards, regardless of how many patients have to suffer for the benefit of our incompetence.

This is a common argument used by doctors, nurses, paramedics, . . . . It makes no sense, but we keep demonstrating that we don’t care.

The people in charge should act responsibly, but they delegate responsibility and we reward them.

Back to the hospital, Vanderbilt University Medical Center (VUMC) is a university medical center, so the standards should be high. VUMC was founded in 1874 and is ranked as one of the best hospitals in America.

There is a drug dispensing machine, from which less-than-killed nurses can obtain almost anything and administer almost anything, without understanding enough to recognize the problem. This is an administrative problem. This was designed by someone with no understanding of risk management.

The over-ride of the selection is not the problem, because emergencies happen and it is sometimes necessary to bypass normal procedures during an emergency. Ambulances are equipped with lights, sirens, and permission to violate certain traffic rules for this reason.

Some of the many blatant problems are:

* The failure of the nurse to have any understanding of the medication supposed to be given

* The failure of the nurse to recognize that the drug being given was not the drug ordered.

* The failure of the nurse to monitor the patient being given a drug for sedation.

* Most of all, the failure of the hospital – the nurses, the doctors, the administrators, to try to make sure that at least these minimum standards are in place.

* How often do nurses in the Neuro ICU give midazolam?

* Why is a nurse, who is clearly not familiar with midazolam, giving midazolam to any patient?

* How is a nurse, working unsupervised in a Neuro ICU not familiar with midazolam?

* What kind of qualifications are required for a nurse to give sedation without supervision?

* Since this nurse was orienting another nurse, what qualifies this nurse to orient anyone?

* Given the side effects of midazolam, why was midazolam ordered without monitoring?

* Given the side effects of midazolam, was it the most appropriate sedative for use in a setting where monitoring is going to be difficult?

* Was it the more rapid onset of sedation, in order to free up the PET scan more quickly and/or avoid having to reschedule the scan, that led to the choice of midazolam?

* How well do any of the doctors understand the pharmacology of midazolam if they are giving orders for a nurse to grab a dose, take it down to the scan, give the drug, and return to the unit, abandoning the monitoring of the patient to the techs in the PET scan?

* This is not a criticism of the techs in PET scan, but are techs authorized to manage sedated patients?

* Even though they will often scan sedated patients, are the techs required to demonstrate any competence at managing sedated patients?
 

The nurses being oriented apparently thought that it is customary to give sedation:

1. without even looking at the name of the medication

2. without confirming by looking at the name again, it before administration

3. without double checking with a nurse, or tech, that the label matches the name of the drug to be given
 

How many of the doctors, responsible for the care of ICU patients, would agree to be sedated, without being monitored, and to have their care handed off to PET scan technicians?

Why didn’t the doctors and nurses see this as a problem before it made the news?

If the problems were reported, nothing appears to have been done to address the problems beyond the usual – Nothing to see here. Move along. or That’s above your pay grade.

That is the primary point I am trying to make.

The problem is well above the pay grade of the nurse.
 

Here is the part that experienced nurses have jumped on immediately:

Why did the nurse think that midazolam needs to be reconstituted?

Vecuronium (most common brand name is Norcuron) is a non-depolarizing neuromuscular-blocker, which comes as a poweder, that needs to be reconstituted.
 


Image source
 

1. Read label instructions?

This nurse has repeatedly demonstrated a need to be supervised, but those responsible for that supervision have apparently ignored their responsibilities in a way that far exceeds any failures by this nurse.

Is it possible that this is a one time event and that the nurse has behaved in an exemplary manner at all times while around doctors and other nurses before this day? It is possible, but the number and severity of the failures on the part of the nurse strongly suggest a pattern of not understanding, not caring, or both. I suspect that any lack of caring is due to a lack of understanding, because I have not yet lost all hope in humanity.

Footnotes:

[1] Nurse charged in fatal drug-swap error pleads not guilty
By Travis Loller
February 20, 2019
Associated Press
Article

.

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

.

Cardiac arrest victim Trudy Jones ‘given placebo’ – rather than experimental epinephrine

 

As part of a study to find out if epinephrine (adrenaline in Commonwealth countries) is safe to use in cardiac arrest, a patient was treated with a placebo, rather than the inadequately tested drug. Some people are upset that the patient did not receive the drug they know nothing about.[1]

The critics are trying to make sure that we never learn.

We need to find out how much harm epinephrine causes, rather than make assumptions based on prejudices.

When used in cardiac arrest, does epinephrine produce a pulse more often?

Yes.

When used in cardiac arrest, does epinephrine produce a good outcome more often?

We don’t know.

In over half a century of use in cardiac arrest, we have not bothered to find out.
 


 

We did try to find out one time, but the media and politicians stopped it.[2]

We would rather harm patients with unreasonable hope, than find out how much harm we are causing to patients.

We would rather continue to be part of a huge, uncontrolled, unapproved, undeclared, undocumented, unethical experiment, than find out what works.

Have we given informed consent to that kind of experimentation?

Ignorance is bliss.

The good news is that the enrollment of patients has finished, so the media and politicians will not be able to prevent us from learning the little that we will be able to learn from this research.[3]

Will the results tell us which patients are harmed by epinephrine?

Probably not – that will require a willingness to admit the limits of what we learn and more research.

What EMS treatments have been demonstrated to improve outcomes from cardiac arrest?

1. High quality chest compressions.
2. Defibrillation, when indicated.

Nothing else.

All other treatments, when tested, have failed to be better than nothing (placebo).

Footnotes:

[1] Cardiac arrest victim Trudy Jones ‘given placebo’
BBC News
23 March 2018
Article

[2] 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. Epub 2011 Jul 2.
PMID: 21745533 [PubMed – in process]

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.

 

[3] Paramedic2 – The Adrenaline Trial
Warwick Medical School
Trial Updates
 

Trial Update – 19 February 2018:
PARAMEDIC2 has finished recruitment and we are therefore no longer issuing ‘No Study’ bracelets. The data collected from the trial is in the process of being analysed and we expect to publish the results in 2018. Once the results have been published, a summary will be provided on the trial website.

 

Edited 12-27-2018 to correct link to pdf of Jacobs study in footnote 2.

.

If your Versed (midazolam) isn’t working, maybe it’s Zofran (ondansetron)

 
If you were giving a lot more midazolam (Versed) by intramuscular injection to stop a seizure and the seizure just would not stop, or got worse, maybe you were giving ondansetron (Zofran).

If you were giving a lot more midazolam by injection to sedate a patient and the sedation just wasn’t having its usual effect, maybe you were giving ondansetron. While rare, there can be very serious side effects from too much ondansetron.
 

Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions. Patients may also be at risk for serotonin syndrome. Serotonin syndrome is associated with increased serotonergic activity in the central nervous system. Most reports of serotonin syndrome have been associated with concomitant use of certain drugs, some commonly used during surgery, such as fentanyl. Some of the reported cases of serotonin syndrome were fatal.[1]

 

How do you recognize serotonin syndrome?
 

Serotonin syndrome (SS) is a group of symptoms that may occur following use of certain serotonergic medications or drugs. [1] The degree of symptoms can range from mild to severe.[2] Symptoms include high body temperature, agitation, increased reflexes, tremor, sweating, dilated pupils, and diarrhea.[1][2] Body temperature can increase to greater than 41.1 °C (106.0 °F).[2] Complications may include seizures and extensive muscle breakdown.[2] [2]

 

2 mg of midazolam is much too low a dose to try to stop a seizure, unless it is the only packaging you have and you are giving 5 intramuscular injections at a time. The best response to prehospital treatment of seizures was by giving 10 mg of intramuscular midazolam to adults (over 40 kg) and 5 mg of intramuscular midazolam to children (under 40 kg).

Maybe you think that is too much midazolam. The highest quality and largest pre-hospital study does not support using lower doses.
 

Our data are consistent with the finding that endotracheal intubation is more commonly a sequela of continued seizures than it is an adverse effect of sedation from benzodiazepines.11 [3]

 

There are other uses for midazolam, so you should be aware of the possibility that what you think is midazolam is really ondansetron.

Are the syringes labeled incorrectly for the contents?
 

Fresenius Kabi USA is voluntarily recalling Lot 6400048 of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection,
USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL.
[1]

 

Based on that, the syringes should be correctly labeled as ondansetron, but they are in blister packs labeled as containing midazolam or they are in boxes of blister packs listed as containing midazolam or both or something else.

If you use this packaging of midazolam, check the lot number, the syringe, and any other labels to make sure that they all agree.

What if you need some ondansetron pre-filled syringes?

Send them back anyway. Maybe only some of the syringes are labeled correctly.

What do the syringes look like?
 


 

What does the ondansetron syringe look like? This one is with a blister pack.
 


 

There are other possibilities for mislabeling that could be much more harmful, so read the syringe before you push anything by any manufacturer.
 


 

That probably would not be as harmful as it seems, because it would be pushed slowly, so it might be metabolized as quickly as it is pushed. The ones below would still be expected to produce a much greater respiratory depression than even an extreme midazolam respiratory depression.
 


 

Footnotes:

[1] Fresenius Kabi Issues Voluntary Nationwide Recall of Midazolam Injection, USP, 2 mg/2 mL Due to Reports of Blister Packages Containing Syringes of Ondansetron Injection, USP, 4 mg/2 mL
For Immediate Release
November 3, 2017
Voluntary Recall
Recall announcement

[2] Serotonin syndrome
Wikipedia
Article

[3] Intramuscular versus intravenous therapy for prehospital status epilepticus.
Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators.
N Engl J Med. 2012 Feb 16;366(7):591-600.
PMID: 22335736 [PubMed – in process]

Free Full Text from N Engl J Med.

.