Vol. 201 October 15, 2018 Medical Facts and Fantasies?

October 15, 2018

Hub thumbnail 2015A baby aspirin a day does not necessarily keep the doctor away.
Daily low dose (81 mg. or a baby tablet) aspirin protects you from having your SECOND heart attack, not your first one. Another recent study confirmed that aspirin gives no such protection to someone who has a normal heart history. A baby aspirin is of NO benefit for primary cardiovascular disease prevention. (Despite these repeated studies many of us continue on our merry way of taking a daily baby aspirin in hopes of preventing “the big one.” )

Ritalin is apparently better than nothing . . . and lots of other things.
ADHD (Attention-Deficit-Hyperactivity-Disorder) in school children is not helped much by non-drug therapy. A 2011 review of 54 studies showed little lasting effectiveness of neurofeedback, child behavioral training, parent training, cognitive behavioral (“talk”) therapy, dietary changes, or herbal and Omega fatty acid supplements when compared to the usual psychostimulant drugs like Ritalin. (This lack of evidence of any benefits from non-drug treatment of this common condition is disappointing. The reviewers themselves call for additional studies.)

There’s An App For It – Among things that your smartphone can do are:

  • Record and transmit a electrocardiogram of your heart rate and rhythm.
  • Ask questions to determine whether you are slipping into a depression, and send a text message to your therapist.
  • Have a trained counselor call you within an hour of you opening up a bluetooth equipped HIV self-test kit to interpret the results for you.
  • Adjust the volume and sound characteristics of the hearing aid in your ear.
  • Operate an automatic pill dispenser filled with your daily medications.
  • Give you a “text neck”. The 60 degree angle of your neck as you text puts about 60 pounds of strain on your spine. (That’s the equivalent of 4 bowling balls).
  • Measure, record, and transmit your blood pressure or blood glucose level.
  • Give you an inaccurate pulse oximetry reading if using a non-FDA approved monitoring app. (In fact, the FDA faced with the existence of about 400,000 health and wellness apps has decided to review 20 apps a year that are directly related to gathering and transmitting clinical data. – FitBits are not included in that category)

Got your flu shot yet?
This year the CDC is recommending the quadrivalent flu vaccine for everyone over 6 months old who does not have a medical contraindication. No particular vaccine brand is recommended over the others. People with egg allergies can safely receive any of the vaccines. ( The Bill and Melinda Gates Foundation is pouring money into research efforts to reduce the potential effects of one of their greatest fear, another flu pandemic.)

Parents know best.
Children sleep better if fed earlier in life. Official pediatric policy used be to start solids at 6 months. Many parents think that starting at 3 months causes longer sleep periods and less sleep problems. A study of 1300 breast-fed infants in England and Wales showed that the parents are right. Duh! (Pediatricians used to recommend starting certain solid foods at even a later age because of potential food allergies. That is no longer true.)

The “other shoe” on probiotics.
The current wisdom that “probiotics are harmless and can benefit everyone” is not necessarily true. The exploding volume of research on our “microbiome” (the bacteria in our intestines) reveals that the bacterial mix in our intestines is unique to each individual (like a fingerprint) and is “good” for us in its natural state. Probiotics can change that mix, and one study shows that some of us have guts that are not only “resistant” to probiotics, but that alteration of our natural mix by probiotics could delay recovery from some illnesses.

Why your visit to your doctor’s office isn’t the same as the “old days”.
It is estimated that a typical primary care physician needs 22 hours a day to address all of the preventive, acute, and chronic needs of an average patient panel of 2,500 patients. This includes all of the insurance-prescribed, electronically embedded (in the electronic medical record – EMR) quality measures tied to the reimbursement of the physician. (This is one reason we patients are filling out more questionnaires, clicking on more boxes on a screen, and spending more time with nurse practitioners and physician assistants when we go to the doctor’s office. “The doc can’t do it all any more.”)

Watch out. More un-immunized children are on their way to school.
A 2017 CDC telephone survey indicates that about 100,000 children in the U.S. born in 2015 and 2016 have not received vaccination against the 14 disease for which shots are recommended. This is an increase from a similar study of children born in 2011.

Too fat? Just take a pill. . . A new kind of pill.
A capsule with a long thin plastic tube is swallowed by the patient. Once in the stomach air is pushed down the thin plastic tube, the capsule expands into a balloon filling 1/3 of the stomach, the patient has sensation of having a full stomach, and the thin tube breaks off and is withdrawn. In about three months the stomach balloon disintegrates, deflates, and is passed out in the stool. It has been approved in Europe and is being tested in the U.S. hoping for FDA approval in 2020. Another start-up company is hoping that their capsule filled with gel that expands in the stomach juices and accomplishes the same thing will also be approved. ( The gel-filled capsule is a bit of deja vu for me. As a chubby pre-teen trying to lose weight, I remember taking a tablespoon of “weight-loss powder” a half-hour before a meal, waiting to let it expand in my stomach, and feeling less hungry  so I ate less. I forget its name, but I do clearly remember the time I was in a particular hurry, ate too soon after the dose, and promptly emptied my over-filling stomach onto my shoes.)

A timely tip for women.
With all the surprise disclosures of “good men” exhibiting past sexual harassment acts and even sexual assaults, how can a woman feel confident that the man she is with is not the aggressive type? A recent study suggests you can just look at his hands. The shorter the index finger is compared to the ring finger, the more aggressive the man may be. This is from a study of 300 Canadian men and women. No correlation of personality to finger lengths was found in women. Researchers associate this finding with “the amount of testosterone that babies are exposed to in utero”. ( Or could it be related to being born North of the 49th parallel?! )

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Vol. 200 October 1, 2018 “Memories Are Made Of This” (apologies to Dean Martin)

October 1, 2018

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The man [or woman] with a clear conscience probably has a poor memory. ~Author Unknown

 

 

He said. She said. Which one has the correct memory? That’s a very good question . . . and there are a variety of answers.

Before the memory is made, of course, perception has to occur. As the police, lawyers, and judges know, perceptions of the same event can vary considerably between witnesses. Much has been written about the unreliability and inaccuracy of eyewitnesses to a crime. Extreme stress during a criminal act, presence of weapons, brief time durations, racial disparities, and lack of significant physical characteristics are some of the causes of much different perceptions. But some of it is due to how our brain works.

As an example of perceptual differences in viewing even non-stressful events click here and watch a video of an attentiveness test. It is a variation of the famous 1999 “Invisible Gorilla” perception test.

In the recent confirmation hearing of a Supreme Court judge dominating our current media only the two principals will be telling their story. Since he denies the event as described by her, and no eyewitness is available, we are back to the reliability of memories.

Memories are thought to be reconstructed like a puzzle rather than being played back like a videotape. Other people questioning the memory, challenging details, asking for repeated retelling (as in the “telephone” party game), or unintentionally giving non-verbal clues can actually alter how the puzzle is reconstructed. Police line-ups as a way of identifying criminals has long thought to be rife with such errors.

False memories have intentionally been created in experiments where researchers present to a number of adults four stories of their own early childhood. Three are true memories. The false story contains some true, irrelevant, but known to the reader, details provided by relatives. Each adult is asked to add any other details they can remember to the stories. In the end one-third of the adults believed that the false memory was true. In follow-up interviews 25% still felt that the false memory was true. This, of course, was a highly structured, experimental manipulation not easily mimicked in real life, but it shows that false memories can be created by outside influences.

Mitchell Garabedian, the lawyer that represented victims of Catholic clergy sexual abuse feels that victims often come forward because they feel obligated to for the sake of others. He also notes that both persons believe wholeheartedly that their memory is true, so that both will appear to be equally credible. (1)  This suggests that lie detector test results are irrelevant to characterizing memories as either true or false.

The debate about whether recovered memory in child abuse cases is false or true flared to a peak in the 1990’s. “Recent debates between differing schools of scientific thought, fueled by the media and by lay organizations with varied political agendas, have left the public confused and misinformed regarding the nature of traumatic memories” – ( this was writtenin in 1994!)  In an effort to reconcile the differences of scientific opinion of recovery memory in child abuse cases, a national symposium of all kinds of experts with all kinds of theories was convened in 2012. It did not produce a consensus, but it did produce a 255 page book that you are welcome to read.  (Full disclosure by my true memory: I did not read the whole thing)

“Emotional arousal appears to increase the likelihood of memory consolidation during the retention (storage) stage of memory (the process of creating a permanent record of information). A number of studies show that over time, memories for neutral stimuli decrease but memories for arousing stimuli remain the same or improve. Others have discovered that memory enhancements for emotional information tend to be greater after longer delays than after relatively short ones. This delayed effect is consistent with the proposal that emotionally arousing memories are more likely to be converted into a relatively permanent trace, whereas memories for non-arousing events are more vulnerable to disruption. Several studies have demonstrated that the presentation of emotionally arousing stimuli (compared to neutral stimuli) results in enhanced memory for central details (details central to the appearance or meaning of the emotional stimuli) and impaired memory for peripheral details.  A few studies have even found that emotionally arousing stimuli enhance memory only after a delay.”

We know from PTSD studies that traumatic memories can be either haunting or forgotten. Traumatic memories that are a single event, involve an adult victim, and receive validation and support are more apt to be retained as a “continuous memory”. (i.e.; a rape, assault) Trauma that is repetitive, involving a child victim, and is followed by denial and secrecy is more apt to produce “disassociation/amnesia” (i.e.; incest, abuse, torture).

After reading this you may still be uncertain about who has the correct memory, as well as being undecided about whether the Senate Judicial Committee hearing was a kangaroo court or not. “A kangaroo court is a judicial tribunal or assembly that blatantly disregards recognized standards of law or justice, and often carries little or no official standing in the territory within which it resides. The term may also apply to a court held by a legitimate judicial authority who intentionally disregards the court’s legal or ethical obligations. A kangaroo court is often held to give the appearance of a fair and just trial, even though the verdict has in reality already been decided before the trial has begun. This could be because of the biases of the decision-maker, or because the structure and operation of the forum result in an inferior brand of adjudication.”

HAVE A NICE DAY! If you do, please make sure to remember it.

References:
1. Boston Globe, Sept 23, 2018, B2, Steve Annear

 


Vol. 198 September 1, 2018 A RX for Play

September 1, 2018

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“Unfortunately both the value and the meaning of play are poorly understood in our hurried society.”
The Hurried Child, 1981

“Play for children buffers toxic stress, builds parental relationships,
and improves executive functioning.”
-The Power of Play,  2018

This month the American Academy of Pediatrics (AAP) recommended that all clinicians write a “prescription for play” for all children at each well child visit. The AAP first touted the benefits of play in 2007.  What’s new about this 2018 report, “The Power of Play”,  is 1) the compilation of 139 scientific studies supporting the benefits of childhood play, 2) the specific recommendation that clinicians give a “prescription to play” to the parents of children at every well child visit in the first two years of life, and 3) the inclusion of a list of specific parental actions and behaviors to help parents actually “fill the prescription”.

What is not new is the knowledge that play is very important for children’s cognitive (academic), social, language, and emotional development. In 1981 (almost 40 years ago!) David Elkind, Ph.D. in The Hurried Child, Growing Up Too Fast Too Soon (1) catalogued how play was one of the antidotes to the toxic stresses on our children at that time. His 1981 list of the sources of that stress on children sound still familiar to us in 2018:

  • early pressure to gain academic skills
  • early intervention to help learning in the early years (concept of “readiness” was disputed)
  •  media presentations of adult clothing and behavior as models for children
  •  changes in the traditional family model (dual-career couples, increased single parent families, single parent dating, increased divorce rate )
  • summer camps (and after school programs) becoming competitive training sites for specific skills
  • Cutting of recess, physical education (“gym period”), art, music and drama from school curriculum
  • increasing modes of passive play (no real-time human interaction; media play is passive).

“Play has been transformed into work. Perhaps the best evidence of the extent to which our children are hurried is the lack of opportunities for genuine unstructured play available to them. Genuine play involves human interaction, mostly child to child but also child to adult. Play is nature’s way of dealing with stress for children as well as adults.” – All written in 1981 by Dr. Elkind.

What are some of the specific ingredients listed by the AAP to fill the 2018 “prescription for play”? (2)

Newborn- 6 months

  • talk to your infant, mimic his or her sounds
  • make various faces at the infant so he or she can mimic you
  • let him or her put safe objects in their mouth

7-12 months

  • put infant in different positions so that he or she can view the world from different angles (“tummy time”)
  • use a mirror to show different faces to your infant
  • Peek a boo is a BIGGIE !
  • give him or her more toys to drop (teaches that actions have effects)
  • let infant safely crawl and explore freely

1-3 years

  • give paper, crayons, etc. to encourage scribbling
  • play make-believe with the child
  • read regularly to the child
  • sing and play rhythms to the child

4-6 years

  • allow child to move between make-believe and reality (pretend making biscuits and then tolerate the “spreading of flour all over the kitchen table”; if you can’t tolerate the mess, maybe change this play into ‘actions have effects’?)
  • tell stories and ask your child what she or he remembers about it
  • encourage a variety of safe physical movements (climbing, somersaults, etc.)

“Play with parents and peers is fundamentally important for developing a suite of 21st century skills in a competitive world that requires collaboration and innovation.”(3)

Dr. Elkind won me over completely when he explained why young children are entranced by dinosaurs; something that has perplexed me for years.
“Dinosaurs provide children with a symbolic and safe way of dealing with the giants in their world, namely adults.” (pg. 196)

Refernces:
1. Also “The Power of Play, Learning What Comes Naturally”, 2007, David Elkind, Ph.D
2. from www.pathways.org
3. Michael Yogman, MD, lead author of The Power of Play, AAP, 2018


Vol. 197 August 1, 2018 GMO Tomatoes?

August 1, 2018

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“ The sad reality is that industry is not really committed to making a better tasting tomato.”
– Harry J. Klee, Ph.D., University of Florida

 

It’s August on Cape Cod, and I have yet to taste a big red luscious locally grown tomato! How long do I have to settle for the bland, tasteless, but very red (they gas green tomatoes with ethylene to turn them red) commercially grown ones?! Is there any hope for a better tasting commercial tomato?

GM (genetic modification) has been going on for centuries through selective breeding and artificial selection by the hands of mankind to improve plants and animals. Pre-Columbian natives, by selecting and re-planting those wild scrubby plants that had bigger, redder, and more fruits, started the development of the beefsteak heirloom tomato we know today. There is probably no vegetable or fruit that we eat today, including corn, soybean, and potatoes, that is not the result of mankind’s genetic selection over thousand of years.

But now those initials, GM or GMO, spark great controversy because scientists can do the genetic selections in a much shorter time in the laboratory. The initial GMO crops introduced by Monsanto in the 1990’s were “transgenic” products;. foreign DNA, even from other species, was introduced or “spliced” into the genes of plants to make them more resistant to Monsanto’s herbicides. Corn and soybean which could thrive in the rain of a new, “more effective” herbicide ignited wide-spread concern and speculation about the long-term effects of the “foreign DNA” GMO crops.

In the same year of 2012 the Tomato Genome Project completed its listing of the 900 million DNA base pairs on 12 chromosomes of the tomato AND a gene-cutting technique dubbed CRISPR  was first described.  Scientists from three universities  published their CRISPR research separately in the same year. UC Berkley , MIT, and Harvard continue the legal battles over the patent rights which will be worth billions. CRISPR is basically a pair of biological scissors that allow scientists to precisely snip and delete part of a gene. It is referred to as “gene-editing”. It is not “transgenic”. No “foreign DNA” is involved or inserted.

For example, for the past 60 years growers have been trying to develop a “jointless” tomato. The classic tomato plant develops a swollen knuckle of tissue in its stem just above the fruit. When the tomato is ripe, the stem knuckle gets a signal from the plant for its cells to die, the stem breaks at this “joint”, and the tomato falls to the ground to happily spread its seeds and make new plants. The problem for the tomato grower who is mechanically harvesting tons of tomatoes is that the residual long stem pierces lots of other tomatoes in the picking process. The damage makes them unsellable. By CRISPRing the gene responsible for the knuckle and deleting it, a “jointless” tomato plant results in a bigger, undamaged crop, and more money for the grower.

Other CRISPR experiments are aimed at developing “self-pruning” tomato plants that are half as tall, less bushy, and with more fruits. Some experiments hope to develop plants that flower earlier, that ignore daylight clues, that require a smaller footprint, and that space their fruit on a stem like an accordion. If you discern that these efforts are all aimed at improving the tomato’s financial return in the market place, you are right. One cynic has stated that the “perfect tomato will be one that exactly matches the size of a MacDonald hamburger… A better tasting tomato always plays second fiddle to market economics.”

CRISPR is great at knocking out or deleting genes. It edits genes. The US Department of Agriculture has determined that crops developed with gene editing mutations are “indistinguishable” from those produced by traditional breeding and “do not require regulatory oversight”. It is a long way from the research lab to the market place via the three agricultural mega-conglomerates, but a variety of start-up companies are developing CRISPR-like technologies for getting cheaper, and maybe better tasting, gene-edited produce to market.

So, just when you hoped that life would be getting simpler and choices might become fewer, you now have to ask yourself a new question, “If it’s GMO, is it transgenic (jury is still out) or just gene-edited (approved)?” Although we may be a long way from getting commercially grown tomatoes that taste as good as our locally grown beefsteak heirlooms, do not fear, CRISPR may soon produce a gluten-free wheat!

Reference: “Tomorrow’s Tomato”, Stephen S. Hall, WIRED, August 2018, pg.053-061


Vol. 196 July 15, 2018 Consequences of Separating Children From Their Parents

July 15, 2018

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“Home Security and Family Values –
Is that an oxymoron?”

 

 

Hundreds of children in immigrant families wishing to enter the U.S. from Mexico have been separated from their parents by U.S. policy. The administration has not released the actual number, but the number of unaccompanied children held in U.S. detention centers jumped up by 20% from 8,000 to a little over 10,000 children after implementation of the “zero tolerance policy”.

In 2016 the Secretary of Home Security John Kelly began to talk about such a separation policy as a deterrent to families seeking entrance either illegally or even if legally seeking asylum on our Mexican border. In response to that proposed policy a coalition of pediatricians, psychiatrists, and social scientists published “Separating Families at the Border – Consequences for Children’s Health and Well-Being” in the New England Journal of Medicine (NEJM) June 15, 2017 and founded the Child Advisory Network   to advocate against the “zero tolerance policy”.

Now, nobody really believes that separating children from their parents, unless the children are being maltreated or abused, is good for the children. Our own legal system has a very high threshold for removing children from their parents. And maybe, administration policy makers were probably counting on this universal belief (in all languages, of course) to make their action an effective deterrent to immigration.

The NEJM article summarized the many studies that document the deleterious effects of separating children from parents; all based on the over-activation of the stress response system of the child’s brain and specific hormone producing organs. Proper balance of that system is necessary for normal physical growth, proper and appropriate regulation of emotions, and maintenance of good health. In fact, such stress and anxiety is apparently cumulative and can ever result in an earlier-than-expected death!

The high costs of separating and detaining the children, especially the costs of finding and supporting foster care for U.S.-citizen children of parents who have already been deported, was cited in this review. In many states the foster care system for American children is overwhelmed and an occasional source of horror stories of maltreatment by foster parents.

Perhaps you’re thinking that these are moot points after the announcement of the reversal of the “zero tolerance policy”, but NPR reported on July 12 that in a response to a court order deadline only 57 of the 100 under the age of 5 years had been reunited with their parents (49 other were not). NPR also reported that the total number of separated children is 3000. The next court order deadline in about two weeks calls for 2000 families to be reunited. Both court orders stem from suits brought by the ACLU against the U.S. Department of Home Security.

Reason cited by the Home Security Department for some “failures to reunite” include criminal charges against a parent(s), parent not available since already deported, and a lack of match between the child’s DNA and the parents’ DNA. Wow, talk about opening up another Pandora’s box for the U.S. border staff, Home Security Department, and our judicial system, already creaking under “zero tolerance policy” consequences. Resolution of those instances of DNA “mismatch” will become another nightmare for already stressed-out families and children who were seeking sanctuary from the stress of living in their own country in the first place; a uniquely modern negative consequence of political policy once again trumping science.


Vol. 195 July 1, 2018 BIG DATA and a whiff of AI in health care

July 1, 2018

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“When it comes to health data, Watson hasn’t been much help.”
-STATNEWS, Ross and Swetlitz. Bos Globe 6/18/18

This week all the newspapers (at least in Massachusetts) have been abuzz with the announcement that Atul Gawande, MD has been picked by three moneyed titans of innovation to head their new company to revolutionize health care. Optimism, promise, and hope is in the air! Kind of like when IBM presented Watson, its supercomputer, in 2015 as the tool to provide workable insights into the financial and clinical dilemmas of U.S. hospitals in 2015 via Watson Health.

How is that working out? Watson Health has access to data on tens of millions patients, in part by spending $9 billion to acquire other companies. It’s initial focus was on developing workable products in oncology, designed to help physicians individualize cancer treatments. “With these acquisitions, IBM will be one of the world’s leading health data, analytics, and insights companies, and the only one that can deliver the unique cognitive capabilities of the Watson platform”, said the general manager of Watson Health in 2015.

They (the newly merged companies) struggled with the basic step of learning about the different forms of cancer and the rapidly changing landscape of treatments. Last week Watson Health laid off people partly because, according to some, even Watson had difficulty in digesting all that data. “…They also don’t understand the generation of information, and how it is used, and whether they can do something different with it,” said Robert Burns, professor of health management at U Penn Wharton School. You can almost hear every primary care physician that is struggling to get their new EMR system to give him/her more information and less data cheering loudly in the background, “We couldn’t have said it better!”

The goal of a great deal of innovative technology in health care is “ “zero patient harm”. if Atul can’t do it all with his surgical checklists and Watson can’t do it all with data from tens of millions of patients , what/who can? How about Artificial Intelligence (AI), aka “machine learning”? AI and machine learning is the converting of data into information without the need for human programmers. For instance, if the computer views enough pictures of different dogs, it will learn to correctly identify a cocker spaniel. I think a real test of AI would be to see if it can recognize a Labradoodle,  or any other of the many poodle cross breeds. (Don’t you sometimes worry about the moral standards of poodles that seem to be eager to mate with any kind of passing breed?)

The building of knowledge from patterns in data, both visual and language, is labeled “computer vision”. In some medical studies “computer vision” is used to monitor actual bedside events and identify omissions or non-compliance in procedures. It has apparently improved rapidly beyond just identifying dogs or skin rashes because of “deep learning”: a type of machine learning that uses “multilayered neural networks whose hierarchical computational design is partly inspired by biologic neutron’s structure.” (1)  Got that? Think Google’s self-driving cars. “Computer vision may soon bring us closer to resolving a seemingly intractable mismatch between the growing complexity of intended clinician behavior and human vulnerability to error.” (2)

So, the effort to cut the Gordian knot of patient safety and cost-effective medicine continues. I suspect that the three titans of innovation have turned to Atul Gawande, a health care innovator who successfully uses clinical insight and re-education to effect change, because they recognize the limitations that are becoming more apparent in big data.

  1.  NEJM April 5, 2018 378:14; 1271-2
  2. Ibid.

Vol. 193 May 15, 2018 Antibiotics are Beneficial: A Reminder

May 15, 2018

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A disease outbreak anywhere is a risk everywhere.”
-Dr. Tom Frieden, Director U.S. CDC

 

We read a lot about the dangers of using too many antibiotics. The popularity of “organic foods” is due in part to their claim to be from “antibiotic-free” animals and plants. Concern about the increasing antibiotic resistance of germs due to antibiotic overuse is real as is frequently described in scientific journals as well as the general press. Why, then, would the New England Journal of Medicine publish an article describing the benefits of random, mass distribution of an oral antibiotic to nearly 100,000 children who had no symptoms or diagnosis! Maybe because that effort reduced the death rate of children aged 1-5 months by 25%!

As you’ll remember in my last blog,  I was impressed by Bill Gate’s knowledge of the medical literature because during his presentation he cited this antibiotic clinical trial which had been published that very same week. Well, full disclosure, he knew about the study because his foundation funded it! This study is the kind of innovative medical study related to global health that the Bill & Melinda Gates Foundation supports. I think it is worthwhile to review the details of the study, if just to remind us that antibiotics are good, that medical science advances on the shoulders of previous work, and that sometimes simple answers, like putting iodine into salt or fluoride into water, can prevent a whole lot of disease.

Previous studies in sub-Saharan Africa showed that blindness caused by trachoma, an infectious disease, could be reduced markedly through the mass distribution of an oral antibiotic, azithromycin. Other studies suggested that the same antibiotic could prevent other infectious deaths like malaria, infectious diarrhea, and pneumonia. It is known that azithromycin affects the transmission of infectious disease, so that treatment of one person might have benefits on others in the same community. The data in two of these studies of trachoma prevention in Ethiopia suggested that mass distribution of azithromycin “might” reduce childhood deaths. Since death (after the neonatal period) is a relatively rare event, even in these settings, the trial had to be conducted in a large population. Hence the need for a large grant to carry it out.

A single dose of oral azithromycin was given to 97,047 children aged from 1 month to 5 years in three African countries during a twice-yearly census. 93,191 children in different communities of the same countries were given a placebo. Over the two-year study the “treated” children received 4 oral doses of azithromycin, each about 6 months apart. Children were identified by the name of the head of the household and GPS coordinates of their location for subsequent censuses. Approval for the study was obtained from 9 ethics committees in 6 countries (3 in the US, 1 in the UK, and 2 in Africa).

The average reduction of annual death rates of children receiving a single dose of the antibiotic every 6 months was 13.5% . Children aged 1 month to 5 months receiving the antibiotic had a mortality rate reduction of 25%. At the conclusion of the trial all the children in the communities of Niger, which has one of the highest child mortality rates in the world and a mortality rate reduction of 18% for all ages in this study, were offered treatment with azithromycin.

This study is a beautiful example of the testing of a simple hypothesis, generated by the results of previous work, using innovative methods, requiring a large population for validity,  and implemented by a multi-national team of medical scientists with a large grant from a private foundation that resulted in clear benefits for better global health.

I, for one, am happy to trumpet some good news about antibiotics and this example of “medical research for all” at its best.

Reference:
Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa, NEJM 378;17, April 26, 2018

 

 

 

 


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